Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT00364793
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098320', 'term': 'efavirenz'}, {'id': 'D016049', 'term': 'Didanosine'}, {'id': 'D000068679', 'term': 'Emtricitabine'}], 'ancestors': [{'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '96 Weeks (Last patient, last visit).', 'description': 'Participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.', 'otherNumAtRisk': 37, 'otherNumAffected': 30, 'seriousNumAtRisk': 37, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymph node palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Steatorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bovine tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '3790', 'spread': '76', 'groupId': 'OG000'}, {'value': '1998', 'spread': '51', 'groupId': 'OG001'}, {'value': '2167', 'spread': '68', 'groupId': 'OG002'}, {'value': '2632', 'spread': '83', 'groupId': 'OG003'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '391', 'spread': '141', 'groupId': 'OG000'}, {'value': '445', 'spread': '57', 'groupId': 'OG001'}, {'value': '648', 'spread': '75', 'groupId': 'OG002'}, {'value': '1185', 'spread': '111', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'Total Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.'}], 'classes': [{'title': 'CVR (NC=F) n=15, 10, 4, 8, 37', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'VR-OC n=9, 9, 3, 6, 27', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'SNAPSHOT n=15, 10, 4, 8, 37', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \\< 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \\< 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'CVR (NC=F) n=15, 10, 4, 8, 37', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'VR-OC n=9, 9, 3, 6, 27', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'SNAPSHOT n=15, 10, 4, 8, 37', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \\< 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \\< 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'CVR (n=15, 10, 4, 8, 37)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'VR-OC(n=11,10 ,4, 7, 32)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \\< 400 c/mL; denominator was all who remained on treatment through Week 24.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'CVR (n=15, 10, 4, 8, 37)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'VR-OC (n=11, 10, 4, 7, 32)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \\< 50 c/mL; denominator was all who remained on treatment through Week 24.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.'}, {'type': 'SECONDARY', 'title': 'Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=13,10,4,7,34)', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000', 'lowerLimit': '5.12', 'upperLimit': '5.92'}, {'value': '5.88', 'groupId': 'OG001', 'lowerLimit': '5.32', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'OG002', 'lowerLimit': '5.38', 'upperLimit': '5.88'}, {'value': '5.50', 'groupId': 'OG003', 'lowerLimit': '4.64', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'OG004', 'lowerLimit': '4.97', 'upperLimit': '5.88'}]}]}, {'title': 'Week 2 (n=12, 9, 4, 5, 30)', 'categories': [{'measurements': [{'value': '-1.89', 'spread': '0.270', 'groupId': 'OG000', 'lowerLimit': '-2.60', 'upperLimit': '-0.93'}, {'value': '-2.26', 'spread': '0.278', 'groupId': 'OG001', 'lowerLimit': '-2.32', 'upperLimit': '-1.73'}, {'value': '-2.42', 'spread': '0.496', 'groupId': 'OG002', 'lowerLimit': '-3.38', 'upperLimit': '-2.11'}, {'value': '-1.93', 'spread': '0.277', 'groupId': 'OG003', 'lowerLimit': '-2.49', 'upperLimit': '-1.85'}, {'value': '-2.11', 'spread': '0.162', 'groupId': 'OG004', 'lowerLimit': '-2.51', 'upperLimit': '-1.36'}]}]}, {'title': 'Week 4 (n=11, 8, 4, 6, 29)', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.372', 'groupId': 'OG000', 'lowerLimit': '-2.81', 'upperLimit': '-0.58'}, {'value': '-2.49', 'spread': '0.308', 'groupId': 'OG001', 'lowerLimit': '-2.86', 'upperLimit': '-1.86'}, {'value': '-2.86', 'spread': '0.160', 'groupId': 'OG002', 'lowerLimit': '-3.14', 'upperLimit': '-2.73'}, {'value': '-3.04', 'spread': '0.343', 'groupId': 'OG003', 'lowerLimit': '-3.24', 'upperLimit': '-2.25'}, {'value': '-2.63', 'spread': '0.195', 'groupId': 'OG004', 'lowerLimit': '-3.06', 'upperLimit': '-1.69'}]}]}, {'title': 'Week 8 (n=11, 10, 3, 7, 31)', 'categories': [{'measurements': [{'value': '-2.73', 'spread': '0.412', 'groupId': 'OG000', 'lowerLimit': '-3.48', 'upperLimit': '-0.76'}, {'value': '-2.91', 'spread': '0.366', 'groupId': 'OG001', 'lowerLimit': '-3.27', 'upperLimit': '-1.54'}, {'value': '-2.92', 'spread': '0.070', 'groupId': 'OG002', 'lowerLimit': '-3.12', 'upperLimit': '-2.90'}, {'value': '-3.27', 'spread': '0.338', 'groupId': 'OG003', 'lowerLimit': '-4.05', 'upperLimit': '-2.59'}, {'value': '-2.92', 'spread': '0.209', 'groupId': 'OG004', 'lowerLimit': '-3.33', 'upperLimit': '-1.69'}]}]}, {'title': 'Week 12 (n=10, 10, 3, 6, 29)', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '0.541', 'groupId': 'OG000', 'lowerLimit': '-4.00', 'upperLimit': '-1.33'}, {'value': '-3.19', 'spread': '0.431', 'groupId': 'OG001', 'lowerLimit': '-3.27', 'upperLimit': '-1.00'}, {'value': '-4.02', 'spread': '0.310', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.18'}, {'value': '-3.31', 'spread': '0.362', 'groupId': 'OG003', 'lowerLimit': '-3.87', 'upperLimit': '-2.95'}, {'value': '-3.14', 'spread': '0.261', 'groupId': 'OG004', 'lowerLimit': '-3.87', 'upperLimit': '-1.63'}]}]}, {'title': 'Week 16 (n=10, 10, 4, 7, 31)', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.527', 'groupId': 'OG000', 'lowerLimit': '-4.18', 'upperLimit': '-1.67'}, {'value': '-3.17', 'spread': '0.496', 'groupId': 'OG001', 'lowerLimit': '-3.55', 'upperLimit': '-0.44'}, {'value': '-4.11', 'spread': '0.240', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.61'}, {'value': '-3.44', 'spread': '0.326', 'groupId': 'OG003', 'lowerLimit': '-4.05', 'upperLimit': '-2.95'}, {'value': '-3.27', 'spread': '0.253', 'groupId': 'OG004', 'lowerLimit': '-4.05', 'upperLimit': '-1.94'}]}]}, {'title': 'Week 24 (n=10, 9, 3, 7, 29)', 'categories': [{'measurements': [{'value': '-3.46', 'spread': '0.610', 'groupId': 'OG000', 'lowerLimit': '-4.24', 'upperLimit': '-1.11'}, {'value': '-3.92', 'spread': '0.525', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-2.03'}, {'value': '-4.18', 'spread': '0.585', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-2.43'}, {'value': '-2.95', 'spread': '0.372', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-2.12'}, {'value': '-3.28', 'spread': '0.278', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-2.03'}]}]}, {'title': 'Week 32 (n=9, 9, 4, 6, 28)', 'categories': [{'measurements': [{'value': '-2.75', 'spread': '0.547', 'groupId': 'OG000', 'lowerLimit': '-4.08', 'upperLimit': '-1.67'}, {'value': '-3.28', 'spread': '0.506', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-1.96'}, {'value': '-3.73', 'spread': '0.276', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.23'}, {'value': '-2.93', 'spread': '0.461', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-1.69'}, {'value': '-3.27', 'spread': '0.259', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-1.81'}]}]}, {'title': 'Week 40 (n=7, 9, 4 ,6, 26)', 'categories': [{'measurements': [{'value': '-4.01', 'spread': '0.434', 'groupId': 'OG000', 'lowerLimit': '-4.24', 'upperLimit': '-1.94'}, {'value': '-4.17', 'spread': '0.435', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-3.28'}, {'value': '-4.02', 'spread': '0.236', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.52'}, {'value': '-2.93', 'spread': '0.620', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-0.87'}, {'value': '-3.93', 'spread': '0.240', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-2.90'}]}]}, {'title': 'Week 48 (n=9, 9, 3, 6, 27)', 'categories': [{'measurements': [{'value': '-2.92', 'spread': '0.551', 'groupId': 'OG000', 'lowerLimit': '-4.18', 'upperLimit': '-1.67'}, {'value': '-3.27', 'spread': '0.469', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-1.95'}, {'value': '-3.27', 'spread': '0.320', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.18'}, {'value': '-2.93', 'spread': '0.622', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-1.69'}, {'value': '-3.18', 'spread': '0.271', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-1.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Week 48', 'description': 'HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.'}, {'type': 'SECONDARY', 'title': 'CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=10, 9, 3, 6, 28)', 'categories': [{'measurements': [{'value': '1518', 'groupId': 'OG000', 'lowerLimit': '829', 'upperLimit': '2202'}, {'value': '1569', 'groupId': 'OG001', 'lowerLimit': '1149', 'upperLimit': '2284'}, {'value': '517', 'groupId': 'OG002', 'lowerLimit': '129', 'upperLimit': '558'}, {'value': '413', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '688'}, {'value': '1144', 'groupId': 'OG004', 'lowerLimit': '529', 'upperLimit': '1930'}]}]}, {'title': 'Week 24 (n=6, 7, 3, 6, 22)', 'categories': [{'measurements': [{'value': '259', 'spread': '410.8', 'groupId': 'OG000', 'lowerLimit': '-180', 'upperLimit': '840'}, {'value': '82', 'spread': '330', 'groupId': 'OG001', 'lowerLimit': '-436', 'upperLimit': '669'}, {'value': '31', 'spread': '818.3', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '2478'}, {'value': '283', 'spread': '195.2', 'groupId': 'OG003', 'lowerLimit': '146', 'upperLimit': '452'}, {'value': '177', 'spread': '185.3', 'groupId': 'OG004', 'lowerLimit': '15', 'upperLimit': '669'}]}]}, {'title': 'Week 48 (n=7, 8, 2, 5, 22)', 'categories': [{'measurements': [{'value': '-258', 'spread': '401.5', 'groupId': 'OG000', 'lowerLimit': '-1313', 'upperLimit': '606'}, {'value': '346', 'spread': '381.8', 'groupId': 'OG001', 'lowerLimit': '-622', 'upperLimit': '846'}, {'value': '971', 'spread': '956.0', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '1927'}, {'value': '284', 'spread': '296.8', 'groupId': 'OG003', 'lowerLimit': '215', 'upperLimit': '330'}, {'value': '196', 'spread': '220.8', 'groupId': 'OG004', 'lowerLimit': '-258', 'upperLimit': '721'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Weeks 24 and 48', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm\\^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.'}, {'type': 'SECONDARY', 'title': 'Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=7, 9, 3, 5, 24)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '40'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '28'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '23'}, {'value': '24', 'groupId': 'OG004', 'lowerLimit': '14', 'upperLimit': '28'}]}]}, {'title': 'Week 24 (n=3, 7, 3, 5, 18)', 'categories': [{'measurements': [{'value': '14', 'spread': '12.0', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '19'}, {'value': '2', 'spread': '2.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '9', 'spread': '3.2', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '9'}, {'value': '10', 'spread': '4.2', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '16'}, {'value': '9', 'spread': '2.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '14'}]}]}, {'title': 'Week 48 (n=5, 8, 2, 5, 20)', 'categories': [{'measurements': [{'value': '5', 'spread': '4.5', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '7'}, {'value': '4', 'spread': '3.5', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '8', 'spread': '8.9', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '17'}, {'value': '11', 'spread': '2.9', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '12'}, {'value': '6', 'spread': '2.1', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Weeks 24 and 48', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '129.5', 'spread': '98', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '49', 'groupId': 'OG001'}, {'value': '93.8', 'spread': '68', 'groupId': 'OG002'}, {'value': '130.8', 'spread': '98', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \\< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars\\*time (µM•h).', 'unitOfMeasure': 'µM•h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.54', 'spread': '63', 'groupId': 'OG000'}, {'value': '19.69', 'spread': '85', 'groupId': 'OG001'}, {'value': '13.16', 'spread': '58', 'groupId': 'OG002'}, {'value': '9.11', 'spread': '73', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '71', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '84', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '51', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '72', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).', 'unitOfMeasure': 'L/h/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Death (Treated Participants)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Deaths (Enrolled Participants, Not treated)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'SAE (Treated Participants)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'AE (All Grades,Treated Participants)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}]}, {'title': 'Grade 2 - 4 AEs (Treated Participants)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 - 4 AEs (Treated Participants)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Related AE (All Grades,Treated Participants)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Discontinued due to AE (Treated Participants)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'CDC Class C AIDS event (Treated Participants)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 96', 'description': 'Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Albumin (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'ALP (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'ALT (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'AST (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5\\*ULN; Gr 2: 2.6 to 5.0\\*ULN; Gr 3: 5.1 to 10.0\\*ULN; Gr 4: \\>10.0\\*ULN. AST Gr 1: 1.25 to 2.5\\*ULN; Gr 2: 2.6 to 5.0\\*ULN; Gr 3: 5.1 to 10.0\\*ULN; Gr 4: \\>10.0\\*ULN. Total bilirubin Gr 1: 1.25 to 1.5\\*ULN; Gr 2: 1.6 to 2.5\\*ULN; Gr 3: 2.6 to 5.0\\*ULN; Gr 4: \\>5.0\\*ULN. ALP (U/L) Gr 1: 1.25 to 2.5\\*ULN, Gr 2: 2.6 to 5.0\\*ULN, Gr 3: 5.1 to 10.0\\*ULN, Gr 4: \\>10.0\\*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to \\<LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: \\< 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Total Cholesterol (n=9,10,4,0,23)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'only fasting samples taken', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Total Cholesterol Fasting (n=0,0,0,7,7)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Glucose High (n=11,10,3,0,24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'only fasting samples taken', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Glucose Low (n=11,10,3,0,24)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'only fasting samples taken', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Glucose High Fasting (n=0,0,0,7,7)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'LDL cholesterol (n=9,10,4,0,23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'only fasting samples taken', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'LDL cholesterol fasting (n=0,0,0,7,7)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'too young to fast, samples not taken', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 \\>300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 \\>=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: \\>1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: \\>500 (\\> 500) mg/dL. Glucose, serum, low, \\>=1 month of age (\\<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: \\<30 (\\<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Chemistry Abnormalities - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Bicarbonate, low (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}]}, {'title': 'Sodium, low (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Sodium High (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Uric Acid (n=12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Calcium High (n= 12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Calcium Low (n= 12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Potassium High (n= 12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Potassium Low (n= 12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Lipase Total (n= 12, 10, 4, 7, 33)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 96', 'description': 'Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - \\< LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: \\<8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: \\>13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: \\<6.1 mg/dL; creatinine Gr1: 1.1-1.3\\*ULN; Gr 2: 1.4-1.8\\*ULN; Gr 3: 1.9-3.4\\*ULN; Gr 4: \\>=3.5\\*ULN; lipase Gr 1: 1.1-1.5\\*ULN; Gr 2: 1.6-3.0\\*ULN; Gr 3: 3.1-5.0\\*ULN; Gr 4: \\>5.0\\*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: \\>7.0 (\\<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: \\>=160 (\\<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: \\>15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematologic Abnormalities - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Hemoglobin (n=11, 10, 4, 7, 32)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Platelet (n=11, 10, 4, 7, 32)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils (n=11, 10, 4, 7, 32)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: \\<6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999\\*10\\^9/L; Gr 2: 50.000-99.999\\*10\\^9/L; Gr 3: 25.000-49.999\\*10\\^9/L; Gr 4: \\<25.000\\*10\\^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500\\*10\\^9/L; Gr 2: 1.500-1.999\\*10\\^9/L; Gr 3: 1.000-1.499\\*10\\^9/L; Gr 4: \\<1.000\\*10\\^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Lack of suppression with Changes (PP)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Viral Load Rebound with Changes(PP)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Viral Failure with Changes (outside 35 day limit)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 48', 'description': 'At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: \\> 3.1\\* the 50% inhibitory concentration (IC50) of the control strain; EFV: \\> 3.3\\* IC50 ; ddI: \\> 2.6\\*IC50. Virologic failure: \\<1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA \\> 10,000 c/mL with prior value \\< 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA \\> 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Resistant; AUC<110 µM•h(n=2,7,2,3,14)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Resistant; AUC>=110 µM•h(n=10,3,2,4,19)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 48', 'description': 'PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)\\*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM\\*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC\\<110 μM\\*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: \\> 3.3\\* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC\\<110 µM•h and number of participants with AUC\\>=110 µM•h.'}, {'type': 'SECONDARY', 'title': 'Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Cmax (n=12, 10, 4, 6)', 'categories': [{'measurements': [{'value': '850', 'spread': '48', 'groupId': 'OG000'}, {'value': '1193', 'spread': '39', 'groupId': 'OG001'}, {'value': '356', 'spread': '69', 'groupId': 'OG002'}, {'value': '376', 'spread': '93', 'groupId': 'OG003'}]}]}, {'title': 'Cmin (n=4, 10, 4, 3)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '132', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '0', 'groupId': 'OG002'}, {'value': '1.25', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were \\<LLOQ in all age groups except \\>=6 months to \\< 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were \\<LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1445', 'spread': '76', 'groupId': 'OG000'}, {'value': '2848', 'spread': '53', 'groupId': 'OG001'}, {'value': '1038', 'spread': '54', 'groupId': 'OG002'}, {'value': '1000', 'spread': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \\< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms\\*time per milliliter (ng•h/mL).', 'unitOfMeasure': 'ng•h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '110', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '42', 'groupId': 'OG001'}, {'value': '113.9', 'spread': '111', 'groupId': 'OG002'}, {'value': '143.0', 'spread': '53', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.88', 'spread': '85', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '30', 'groupId': 'OG001'}, {'value': '11.36', 'spread': '116', 'groupId': 'OG002'}, {'value': '10.34', 'spread': '70', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).', 'unitOfMeasure': 'L/h/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.1374', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.859', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '1.007', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '0.214', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Week 60 (n=7, 8, 3, 4, 22)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=7, 7, 2, 4, 20)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Week 84 (n=7, 7, 2, 4, 20)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=7, 6, 2, 4, 19)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 60, 72, 84, and 96', 'description': 'Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \\< 400 c/mL; denominator was all who remained on treatment through the specific week.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Week 60 (n=7, 8, 3, 4, 22)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=7, 7, 2, 4, 20)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Week 84 (n=7, 7, 2, 4, 20)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=7, 6, 2, 4, 19)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 60, 72, 84, and 96', 'description': 'Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \\< 50 c/mL; denominator was all who remained on treatment through the specific week.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.'}, {'type': 'SECONDARY', 'title': 'Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=13,10,4,7,34)', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000', 'lowerLimit': '5.12', 'upperLimit': '5.92'}, {'value': '5.88', 'groupId': 'OG001', 'lowerLimit': '5.32', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'OG002', 'lowerLimit': '5.38', 'upperLimit': '5.88'}, {'value': '5.50', 'groupId': 'OG003', 'lowerLimit': '4.64', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'OG004', 'lowerLimit': '4.97', 'upperLimit': '5.88'}]}]}, {'title': 'Week 60 (n=7, 8, 3, 4, 22)', 'categories': [{'measurements': [{'value': '-3.92', 'spread': '0.458', 'groupId': 'OG000', 'lowerLimit': '-418', 'upperLimit': '-1.94'}, {'value': '-3.44', 'spread': '0.539', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-1.46'}, {'value': '-3.26', 'spread': '0.322', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '-3.18'}, {'value': '-3.48', 'spread': '0.575', 'groupId': 'OG003', 'lowerLimit': '-4.10', 'upperLimit': '-2.32'}, {'value': '-3.50', 'spread': '0.259', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-1.94'}]}]}, {'title': 'Week 72 (n=7, 6, 1, 3, 17)', 'categories': [{'measurements': [{'value': '-4.08', 'spread': '0.438', 'groupId': 'OG000', 'lowerLimit': '-4.24', 'upperLimit': '-1.94'}, {'value': '-2.75', 'spread': '0.603', 'groupId': 'OG001', 'lowerLimit': '-418', 'upperLimit': '-1.83'}, {'value': '-3.20', 'spread': 'NA', 'groupId': 'OG002', 'lowerLimit': '-3.20', 'upperLimit': '-3.20'}, {'value': '-4.18', 'spread': '0.410', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-2.95'}, {'value': '-3.45', 'spread': '0.290', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-2.21'}]}]}, {'title': 'Week 84 (n=7, 7, 2, 4, 20)', 'categories': [{'measurements': [{'value': '-4.08', 'spread': '0.438', 'groupId': 'OG000', 'lowerLimit': '-4.24', 'upperLimit': '-1.94'}, {'value': '-3.28', 'spread': '0.563', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-1.54'}, {'value': '-2.18', 'spread': '1.022', 'groupId': 'OG002', 'lowerLimit': '-3.20', 'upperLimit': '-1.16'}, {'value': '-3.51', 'spread': '0.583', 'groupId': 'OG003', 'lowerLimit': '-4.13', 'upperLimit': '02.32'}, {'value': '-3.37', 'spread': '0.283', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-1.81'}]}]}, {'title': 'Week 96 (n=7, 6, 2, 4, 19)', 'categories': [{'measurements': [{'value': '-3.82', 'spread': '0.423', 'groupId': 'OG000', 'lowerLimit': '-4.18', 'upperLimit': '-1.94'}, {'value': '-3.73', 'spread': '0.686', 'groupId': 'OG001', 'lowerLimit': '-4.18', 'upperLimit': '-1.19'}, {'value': '-2.15', 'spread': '0.848', 'groupId': 'OG002', 'lowerLimit': '-2.99', 'upperLimit': '-1.30'}, {'value': '-3.57', 'spread': '0.597', 'groupId': 'OG003', 'lowerLimit': '-4.18', 'upperLimit': '-2.32'}, {'value': '-3.45', 'spread': '0.296', 'groupId': 'OG004', 'lowerLimit': '-4.18', 'upperLimit': '-1.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Weeks 60, 72, 84, and 96', 'description': 'HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.'}, {'type': 'SECONDARY', 'title': 'CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=10,9,3,6,28)', 'categories': [{'measurements': [{'value': '1518', 'groupId': 'OG000', 'lowerLimit': '829', 'upperLimit': '2202'}, {'value': '1569', 'groupId': 'OG001', 'lowerLimit': '1149', 'upperLimit': '2284'}, {'value': '517', 'groupId': 'OG002', 'lowerLimit': '129', 'upperLimit': '558'}, {'value': '413', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '688'}, {'value': '1144', 'groupId': 'OG004', 'lowerLimit': '529', 'upperLimit': '1930'}]}]}, {'title': 'Week 60 (n=6, 6, 2,3,17)', 'categories': [{'measurements': [{'value': '-870', 'groupId': 'OG000', 'lowerLimit': '-1331', 'upperLimit': '-315'}, {'value': '-914', 'groupId': 'OG001', 'lowerLimit': '-1509', 'upperLimit': '725'}, {'value': '580', 'groupId': 'OG002', 'lowerLimit': '-11', 'upperLimit': '1171'}, {'value': '676', 'groupId': 'OG003', 'lowerLimit': '506', 'upperLimit': '887'}, {'value': '-315', 'groupId': 'OG004', 'lowerLimit': '-1331', 'upperLimit': '676'}]}]}, {'title': 'Week 72 (n=5, 7, 1, 3, 16)', 'categories': [{'measurements': [{'value': '-1178', 'groupId': 'OG000', 'lowerLimit': '-1422', 'upperLimit': '-588'}, {'value': '234', 'groupId': 'OG001', 'lowerLimit': '-1540', 'upperLimit': '624'}, {'value': '-50', 'groupId': 'OG002', 'lowerLimit': '-50', 'upperLimit': '-50'}, {'value': '620', 'groupId': 'OG003', 'lowerLimit': '619', 'upperLimit': '811'}, {'value': '92', 'groupId': 'OG004', 'lowerLimit': '-1300', 'upperLimit': '620'}]}]}, {'title': 'Week 84 (n=6, 7, 1, 3, 17)', 'categories': [{'measurements': [{'value': '-937', 'groupId': 'OG000', 'lowerLimit': '-1331', 'upperLimit': '-155'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '-1416', 'upperLimit': '316'}, {'value': '101', 'groupId': 'OG002', 'lowerLimit': '101', 'upperLimit': '101'}, {'value': '497', 'groupId': 'OG003', 'lowerLimit': '339', 'upperLimit': '722'}, {'value': '59', 'groupId': 'OG004', 'lowerLimit': '-1304', 'upperLimit': '334'}]}]}, {'title': 'Week 96 (n=6, 6, 1, 3, 16)', 'categories': [{'measurements': [{'value': '-834', 'groupId': 'OG000', 'lowerLimit': '-1437', 'upperLimit': '-176'}, {'value': '-43', 'groupId': 'OG001', 'lowerLimit': '-1291', 'upperLimit': '222'}, {'value': '402', 'groupId': 'OG002', 'lowerLimit': '402', 'upperLimit': '402'}, {'value': '744', 'groupId': 'OG003', 'lowerLimit': '295', 'upperLimit': '1243'}, {'value': '-40', 'groupId': 'OG004', 'lowerLimit': '-1185', 'upperLimit': '314'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Weeks 60, 72, 84, and 96', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm\\^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.'}, {'type': 'SECONDARY', 'title': 'Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'OG004', 'title': 'EFV+ddI+FTC in All Participants', 'description': 'All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'classes': [{'title': 'Baseline (n=7,9,3,5,24)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '40'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '28'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '23'}, {'value': '24', 'groupId': 'OG004', 'lowerLimit': '14', 'upperLimit': '28'}]}]}, {'title': 'Week 60 (n=3,6,2,3,14)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '13'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '5'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '15'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '26'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '13'}]}]}, {'title': 'Week 72 (n=2,7,1,3,13)', 'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '-10'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '13'}, {'value': '-1', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '-1'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '11', 'upperLimit': '26'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '-5', 'upperLimit': '12'}]}]}, {'title': 'Week 84 (n=3,7,1,3,14)', 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-22', 'upperLimit': '21'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '34'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '12'}]}]}, {'title': 'Week 96 (n=3,6,1,3,13)', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '15'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '28'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Weeks 60, 72, 84, and 96', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'FG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'FG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'FG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Poor or non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'No longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study initiated February 2007 and completed July 2013. All participants enrolled in countries where efavirenz (EFV) oral solution was not commercially available could remain on study until their 7th birthday or until they were able to swallow EFV capsules (whichever occurred first).', 'preAssignmentDetails': '56 participants were enrolled but 19 were never treated. Reasons for not treating: 2 deaths, 1 lost to follow up, 6 other (not specified), 9 no longer met study criteria, 1 withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'EFV+ddI+FTC in Infants >=3 Months to < 6 Months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'BG001', 'title': 'EFV+ddI+FTC in Infants >=6 Months to < 2 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'BG002', 'title': 'EFV+ddI+FTC in Children >= 2 Years to < 3 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'BG003', 'title': 'EFV+ddI+FTC in Children >= 3 Years to <= 6 Years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.392', 'groupId': 'BG000', 'lowerLimit': '0.296', 'upperLimit': '0.501'}, {'value': '0.825', 'groupId': 'BG001', 'lowerLimit': '0.586', 'upperLimit': '1.906'}, {'value': '2.313', 'groupId': 'BG002', 'lowerLimit': '2.094', 'upperLimit': '2.995'}, {'value': '3.922', 'groupId': 'BG003', 'lowerLimit': '2.998', 'upperLimit': '6.976'}, {'value': '0.663', 'groupId': 'BG004', 'lowerLimit': '0.296', 'upperLimit': '6.976'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Ethnicity was not collected because the study was conducted outside of the United States.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Panama', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Viral Load (log10 c/mL)', 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'groupId': 'BG000', 'lowerLimit': '3.34', 'upperLimit': '6.74'}, {'value': '5.88', 'groupId': 'BG001', 'lowerLimit': '2.12', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'BG002', 'lowerLimit': '4.88', 'upperLimit': '5.88'}, {'value': '5.26', 'groupId': 'BG003', 'lowerLimit': '3.38', 'upperLimit': '5.88'}, {'value': '5.88', 'groupId': 'BG004', 'lowerLimit': '2.12', 'upperLimit': '6.74'}]}]}], 'paramType': 'MEDIAN', 'description': 'Human immunodeficiency virus (HIV) ribonucleic acid (RNA) values ≥ 1,000 copies per milliliter (c/mL) were considered evidence of infection. HIV RNA measures the viral load and was first measured using the ultrasensitive and standard Roche Amplicor Polymerase Chain Reaction (PCR), version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method.', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'HIV RNA Viral Load Category', 'classes': [{'title': '< 30,000 copies/mL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': '30,000 to <100,000 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': '100,000 to <500,000 copies/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': '500,000 to <=750,000 copies/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': '>750,000 copies/mL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Human immunodeficiency virus (HIV) ribonucleic acid (RNA) values greater than, equal to (≥) 1,000 copies per milliliter (c/mL) were considered evidence of infection. Categories listed indicate the plasma viral load prior to study treatment (Baseline). HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method.', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Cell Count (n=13, 9, 3, 7, 32)', 'classes': [{'categories': [{'measurements': [{'value': '1785', 'groupId': 'BG000', 'lowerLimit': '200', 'upperLimit': '3584'}, {'value': '1569', 'groupId': 'BG001', 'lowerLimit': '516', 'upperLimit': '2879'}, {'value': '517', 'groupId': 'BG002', 'lowerLimit': '129', 'upperLimit': '558'}, {'value': '540', 'groupId': 'BG003', 'lowerLimit': '11', 'upperLimit': '1363'}, {'value': '1144', 'groupId': 'BG004', 'lowerLimit': '11', 'upperLimit': '3584'}]}]}], 'paramType': 'MEDIAN', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\\^3). Not all treated participants provided a measurement for this baseline parameter (n=number of participants with this baseline measurement).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Treated participants who received at least one dose of study drug (EFV) were analyzed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-11', 'studyFirstSubmitDate': '2006-08-15', 'resultsFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2006-08-15', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-06', 'studyFirstPostDateStruct': {'date': '2006-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.'}, {'measure': 'Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \\< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars\\*time (µM•h).'}, {'measure': 'Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).'}, {'measure': 'Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants', 'timeFrame': 'Week 48', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \\< 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \\< 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.'}, {'measure': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants', 'timeFrame': 'Week 48', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \\< 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \\< 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.'}, {'measure': 'The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants', 'timeFrame': 'Week 24', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \\< 400 c/mL; denominator was all who remained on treatment through Week 24.'}, {'measure': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants', 'timeFrame': 'Week 24', 'description': 'Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \\< 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \\< 50 c/mL; denominator was all who remained on treatment through Week 24.'}, {'measure': 'Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants', 'timeFrame': 'Baseline through Week 48', 'description': 'HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants', 'timeFrame': 'Baseline to Weeks 24 and 48', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm\\^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants', 'timeFrame': 'Baseline to Weeks 24 and 48', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events', 'timeFrame': 'Baseline to Week 96', 'description': 'Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).'}, {'measure': 'Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5\\*ULN; Gr 2: 2.6 to 5.0\\*ULN; Gr 3: 5.1 to 10.0\\*ULN; Gr 4: \\>10.0\\*ULN. AST Gr 1: 1.25 to 2.5\\*ULN; Gr 2: 2.6 to 5.0\\*ULN; Gr 3: 5.1 to 10.0\\*ULN; Gr 4: \\>10.0\\*ULN. Total bilirubin Gr 1: 1.25 to 1.5\\*ULN; Gr 2: 1.6 to 2.5\\*ULN; Gr 3: 2.6 to 5.0\\*ULN; Gr 4: \\>5.0\\*ULN. ALP (U/L) Gr 1: 1.25 to 2.5\\*ULN, Gr 2: 2.6 to 5.0\\*ULN, Gr 3: 5.1 to 10.0\\*ULN, Gr 4: \\>10.0\\*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to \\<LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: \\< 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 \\>300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 \\>=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: \\>1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: \\>500 (\\> 500) mg/dL. Glucose, serum, low, \\>=1 month of age (\\<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: \\<30 (\\<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.'}, {'measure': 'Number of Participants With Serum Chemistry Abnormalities - Treated Participants', 'timeFrame': 'Baseline to Week 96', 'description': 'Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - \\< LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: \\<8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: \\>13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: \\<6.1 mg/dL; creatinine Gr1: 1.1-1.3\\*ULN; Gr 2: 1.4-1.8\\*ULN; Gr 3: 1.9-3.4\\*ULN; Gr 4: \\>=3.5\\*ULN; lipase Gr 1: 1.1-1.5\\*ULN; Gr 2: 1.6-3.0\\*ULN; Gr 3: 3.1-5.0\\*ULN; Gr 4: \\>5.0\\*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: \\>7.0 (\\<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: \\>=160 (\\<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: \\>15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.'}, {'measure': 'Number of Participants With Hematologic Abnormalities - Treated Participants', 'timeFrame': 'Baseline to Week 96', 'description': 'Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: \\<6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999\\*10\\^9/L; Gr 2: 50.000-99.999\\*10\\^9/L; Gr 3: 25.000-49.999\\*10\\^9/L; Gr 4: \\<25.000\\*10\\^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500\\*10\\^9/L; Gr 2: 1.500-1.999\\*10\\^9/L; Gr 3: 1.000-1.499\\*10\\^9/L; Gr 4: \\<1.000\\*10\\^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).'}, {'measure': 'Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound', 'timeFrame': 'Baseline to Week 48', 'description': 'At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: \\> 3.1\\* the 50% inhibitory concentration (IC50) of the control strain; EFV: \\> 3.3\\* IC50 ; ddI: \\> 2.6\\*IC50. Virologic failure: \\<1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA \\> 10,000 c/mL with prior value \\< 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.'}, {'measure': 'Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population', 'timeFrame': 'Baseline to Week 48', 'description': 'PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)\\*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM\\*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC\\<110 μM\\*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: \\> 3.3\\* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).'}, {'measure': 'Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were \\<LLOQ in all age groups except \\>=6 months to \\< 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were \\<LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.'}, {'measure': 'AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \\< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms\\*time per milliliter (ng•h/mL).'}, {'measure': 'CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).'}, {'measure': 'CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).'}, {'measure': 'Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population', 'timeFrame': 'Week 2', 'description': 'Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).'}, {'measure': 'The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants', 'timeFrame': 'Weeks 60, 72, 84, and 96', 'description': 'Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \\< 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \\< 400 c/mL; denominator was all who remained on treatment through the specific week.'}, {'measure': 'The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants', 'timeFrame': 'Weeks 60, 72, 84, and 96', 'description': 'Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \\< 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \\< 50 c/mL; denominator was all who remained on treatment through the specific week.'}, {'measure': 'Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants', 'timeFrame': 'Baseline through Weeks 60, 72, 84, and 96', 'description': 'HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants', 'timeFrame': 'Baseline to Weeks 60, 72, 84, and 96', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm\\^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}, {'measure': 'Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants', 'timeFrame': 'Baseline to Weeks 60, 72, 84, and 96', 'description': 'A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV, Pediatric'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '26379163', 'type': 'DERIVED', 'citation': 'Pavia-Ruz N, Rossouw M, Saez-Llorens X, Bunupuradah T, Taylor M, Yang R, Sevinsky H, Krystal M, Lataillade M, Seekins D, Biguenet S. Efavirenz Capsule Sprinkle and Liquid Formulations With Didanosine and Emtricitabine in HIV-1-infected Infants and Children 3 Months to 6 Years of Age: Study AI266-922. Pediatr Infect Dis J. 2015 Dec;34(12):1355-60. doi: 10.1097/INF.0000000000000913.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected; \\>=3 months of age to \\<=6 years of age (at time of treatment); screening plasma viral load \\>=1000 copies/mL\n\nExclusion Criteria:\n\n* Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening'}, 'identificationModule': {'nctId': 'NCT00364793', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-infected Infants and Children 3 Months to 6 Years of Age.', 'orgStudyIdInfo': {'id': 'AI266-922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EFV+ddI+FTC in patients >= 3 months to < 6 months', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.', 'interventionNames': ['Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)']}, {'type': 'EXPERIMENTAL', 'label': 'EFV+ddI+FTC in patients >=6 months to < 2 years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.', 'interventionNames': ['Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)']}, {'type': 'EXPERIMENTAL', 'label': 'EFV+ddI+FTC in patients >= 2 years to < 3 years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.', 'interventionNames': ['Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)']}, {'type': 'EXPERIMENTAL', 'label': 'EFV+ddI+FTC in patients >= 3 years to <= 6 years', 'description': 'EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.', 'interventionNames': ['Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)']}], 'interventions': [{'name': 'Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)', 'type': 'DRUG', 'otherNames': ['Sustiva', 'BMS-561525'], 'description': 'Oral Solution, Capsules or Tablets, Oral, once daily\n\nEfavirenz (EFV) per weight-based dosing nomogram (max 720 mg)\n\nDidanosine (ddI) 240 mg/m2 (max 400 mg)\n\nEmtricitabine (FTC) 6 mg/kg (max 200 mg)\n\nWhere EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer);\n\nWhere EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)', 'armGroupLabels': ['EFV+ddI+FTC in patients >= 2 years to < 3 years', 'EFV+ddI+FTC in patients >= 3 months to < 6 months', 'EFV+ddI+FTC in patients >= 3 years to <= 6 years', 'EFV+ddI+FTC in patients >=6 months to < 2 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution'}, {'zip': '1425', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Local Institution'}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Local Institution', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '28019', 'city': 'Colima', 'state': 'Colima', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.24473, 'lon': -103.7127}}, {'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44520', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06720', 'city': 'Df', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution'}, {'zip': '58000', 'city': 'Morelia', 'state': 'Michioacan', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '72000', 'city': 'Puebla City', 'state': 'Puebla', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '78240', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '0816-00383', 'city': 'Panama City', 'country': 'Panama', 'facility': 'Local Institution', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Local Institution', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '2092', 'city': 'Westdene', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Local Institution', 'geoPoint': {'lat': -26.17533, 'lon': 27.98757}}, {'zip': '7505', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Local Institution', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Local Institution', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Local Institution', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}