Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-03-08 @ 11:20 PM
Study NCT ID:
NCT01818258
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2013-01-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IMPAACT.ctgov@fstrf.org', 'phone': '(919) 405-1429', 'title': 'IMPAACT Clinicaltrials.gov Coordinator', 'organization': 'Organization: Family Health International (FHI 360)'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Children with moderate malnutrition were not enrolled in the study by design'}}, 'adverseEventsModule': {'timeFrame': 'From study entry to study completion at Week 48 or premature study discontinuation', 'description': 'Serious Adverse Event (SAE) Reporting Category \\[v2.0 of the DAIDS expedited adverse event Manual\\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.', 'eventGroups': [{'id': 'EG000', 'title': 'Severe Malnutrition', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 3, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Normal Nutrition/Mild Malnutrition', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 25, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tympanic membrane hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Plasmodium falciparum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinea faciei', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Poor feeding infant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Underweight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Selective eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Use of accessory respiratory muscles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Grade 3 or Higher Adverse Events Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison for number who experienced at least one grade 3 or higher adverse event. 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Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) of Lamivudine (3TC)', 'unitOfMeasure': 'ng*hours/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with 3TC AUC data at week 1 and at week 12 or 24'}, {'type': 'PRIMARY', 'title': 'Plasma Clearance of Lamivudine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': '3TC CL/F at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '12.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '11.5'}]}]}, {'title': '3TC CL/F at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '15.4'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '8.1'}]}]}, {'title': '3TC CL/F at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '9.0'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'estimateComment': 'Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.8', 'ciUpperLimit': '2.3', 'estimateComment': 'Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.4', 'estimateComment': 'Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of Lamivudine (3TC)', 'unitOfMeasure': 'L/hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with 3TC CL/F data at week 1 and at week 12 or 24'}, {'type': 'PRIMARY', 'title': 'Steady-state Zidovudine Area Under the Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'ZDV AUC at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2,261.0', 'groupId': 'OG000', 'lowerLimit': '1,652.0', 'upperLimit': '3,094.4'}, {'value': '1,774.0', 'groupId': 'OG001', 'lowerLimit': '1,079.6', 'upperLimit': '2,915.1'}]}]}, {'title': 'ZDV AUC at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1,826.0', 'groupId': 'OG000', 'lowerLimit': '977.8', 'upperLimit': '3,410.0'}, {'value': '1,335.7', 'groupId': 'OG001', 'lowerLimit': '758.5', 'upperLimit': '2,352.2'}]}]}, {'title': 'ZDV AUC at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2,449.7', 'groupId': 'OG000', 'lowerLimit': '2,053.5', 'upperLimit': '2,922.5'}, {'value': '1,609.3', 'groupId': 'OG001', 'lowerLimit': '1,306.7', 'upperLimit': '1,981.9'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.2', 'estimateComment': 'Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.0', 'estimateComment': 'Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.2', 'ciUpperLimit': '2.0', 'estimateComment': 'Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) of zidovudine (ZDV)', 'unitOfMeasure': 'ng*hours/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with ZDV AUC data at week 1 and at week 12 or 24'}, {'type': 'PRIMARY', 'title': 'Plasma Clearance of Zidovudine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'ZDV CL/F at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '49.5'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '97.9'}]}]}, {'title': 'ZDV CL/F at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '95.8'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '148.9'}]}]}, {'title': 'ZDV CL/F at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '33.0', 'upperLimit': '50.4'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '51.7', 'upperLimit': '79.1'}]}]}], 'analyses': [{'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.1', 'estimateComment': 'Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.4', 'estimateComment': 'Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.5', 'ciUpperLimit': '0.8', 'estimateComment': 'Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of Zidovudine (ZDV)', 'unitOfMeasure': 'L/hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with ZDV CL/F data at week 1 and at week 12 or 24'}, {'type': 'SECONDARY', 'title': 'Minimum Trough Concentration (Ctrough) of Lopinavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.29', 'estimateComment': 'Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \\>= 1 ug/mL through 48 weeks', 'groupDescription': 'Odds ratio (SAM/non-SAM) of Ctrough \\>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \\>=1 ug/mL).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 4, 8, 12, 16, 24, 36 and 48 weeks following study entry', 'description': 'Count (%) of participants with minimum trough concentration (Ctrough) of steady-state Lopinavir \\>= 1 ug/mL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with minimum trough concentration of LPV data'}, {'type': 'SECONDARY', 'title': 'Free Fraction of LPV at Hour 2 Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '-0.9', 'estimateComment': 'Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV', 'groupDescription': 'Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '-1.1', 'estimateComment': 'Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV', 'groupDescription': 'Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '4.4', 'estimateComment': 'Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV', 'groupDescription': 'Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 12 and 24', 'description': 'Free fraction of steady-state lopinavir at 2 hours post dose', 'unitOfMeasure': 'Percent of Unbound LPV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with LPV free fraction data available'}, {'type': 'SECONDARY', 'title': 'Change in HIV Viral Load From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Change in Log10 Viral Load between Baseline and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '-0.7'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-1.4'}]}]}, {'title': 'Change in Log10 Viral Load between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-0.9'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '-1.7'}]}]}, {'title': 'Change in Log10 Viral Load between Baseline and Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.0'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '-1.8'}]}]}, {'title': 'Change in Log10 Viral Load between Baseline and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.1'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '-1.9'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.7', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.8', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.8', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.8', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 12, 24, 36 and 48', 'description': 'Change from baseline in plasma HIV RNA viral load', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at baseline and timepoint of interest (week 12, 24, 36, or 48)'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load <400 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline Comparison, with null hypothesis of no difference between cohorts.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 12 Comparison, with null hypothesis of no difference between cohorts.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 24 Comparison, with null hypothesis of no difference between cohorts.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 48 Comparison, with null hypothesis of no difference between cohorts.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and weeks 12, 24, and 48', 'description': 'Count (%) of participants with plasma HIV RNA viral load \\<400 copies/mL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at baseline and timepoint of interest (week 12, 24, or 48)'}, {'type': 'SECONDARY', 'title': 'Change in CD4 Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Change in CD4 Percent at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.8'}]}]}, {'title': 'Change in CD4 Percent at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '13.7'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '9.6'}]}]}, {'title': 'Change in CD4 Percent at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '14.4'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '9.5'}]}]}, {'title': 'Change in CD4 Percent at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '17.1'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '9.1'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '4.4', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '7.6', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '7.8', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.1', 'ciLowerLimit': '1.1', 'ciUpperLimit': '11.0', 'estimateComment': 'Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition', 'groupDescription': 'Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 12, 24, 36 and 48', 'description': 'Change in CD4 percent from baseline', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CD4 percent data at baseline and timepoint of interest (week 12, 24, 36, or 48)'}, {'type': 'SECONDARY', 'title': 'Change in WHO Weight-for-height Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.9'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.5'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.4'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '1.77', 'ciUpperLimit': '2.91', 'groupDescription': 'Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.73', 'ciLowerLimit': '2.09', 'ciUpperLimit': '3.37', 'groupDescription': 'Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Change in WHO weight-for-height Z-score from entry. A Z-score indicates the number of standard deviations the measurement is away from the mean. A Z-score of 0 is equal to the mean of the reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. The reference population was determined by the World Health Organization for children from 0 up to 5 years.', 'unitOfMeasure': 'Z-Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with weight and height data available'}, {'type': 'SECONDARY', 'title': 'Change in Mid-upper Arm Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'OG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.6'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.96', 'ciUpperLimit': '3.28', 'groupDescription': 'Null hypothesis: change in MUAC from entry to week 24 equal to 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '2.83', 'ciUpperLimit': '4.24', 'groupDescription': 'Null hypothesis: change in MUAC from entry to week 48 equal to 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Change in mid-upper arm circumference (MUAC) from entry', 'unitOfMeasure': 'centimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with MUAC data available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'FG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unable to Travel to Clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 52 participants, 25 in the Severe Acute Malnutrition (SAM) cohort and 27 in the non-SAM cohort, enrolled over a period of 12 months between October 26, 2015 and October 21, 2016. The SAM cohort was slower to enroll. Participants were enrolled from 5 sites in 4 African countries: Malawi, Tanzania, Uganda, and Zimbabwe.', 'preAssignmentDetails': 'Children with severe acute malnutrition (SAM) during the screening period were enrolled into the study 10-18 days after starting nutritional rehabilitation, and were required to show clinical improvement. SAM/non-SAM cohort assignments were determined during screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Severe Malnutrition Cohort', 'description': 'Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'BG001', 'title': 'Normal Nutrition/Mild Malnutrition Cohort', 'description': 'Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '19.1', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '19.2', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Uganda', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Malawi', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'World Health Organization (WHO) Weight-for-Height Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '-0.7', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '-2.0', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A Z-score indicates the number of standard deviations the measurement is away from the mean. A Z-score of 0 is equal to the mean of the reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. The reference population was determined by the World Health Organization for children from 0 up to 5 years.', 'unitOfMeasure': 'Z-Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mid-Upper Arm Circumference', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log10 Plasma HIV RNA Viral Load', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log 10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Percent', 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '20.2', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nutritional Cohort Subgroup', 'classes': [{'categories': [{'title': 'Severe Malnutrition', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Mild Malnutrition', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Normal Nutrition', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-03', 'size': 2531666, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2021-06-08T20:57', 'hasProtocol': True}, {'date': '2018-08-20', 'size': 705184, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-11T11:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-19', 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade 3 or Higher Adverse Events Through 24 Weeks', 'timeFrame': 'From week 0 to week 24', 'description': 'Number (percent) of participants with at least one grade 3 or higher adverse event (AE) regardless of the relationship to study drugs.'}, {'measure': 'Grade 3 or Higher Adverse Events Related to Study Drugs Through Week 24', 'timeFrame': 'From week 0 to week 24', 'description': 'Number (percent) of participants with at least one Grade 3 or higher adverse event related to study drugs'}, {'measure': 'Steady-state Lopinavir Area Under the Curve', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) for Lopinavir (LPV)'}, {'measure': 'Plasma Clearance of Lopinavir', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of LPV'}, {'measure': 'Steady-state Ritonavir Area Under the Curve', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) for Ritonavir (RTV)'}, {'measure': 'Plasma Clearance of Ritonavir', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of RTV'}, {'measure': 'Steady-state Lamivudine Area Under the Curve', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) of Lamivudine (3TC)'}, {'measure': 'Plasma Clearance of Lamivudine', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of Lamivudine (3TC)'}, {'measure': 'Steady-state Zidovudine Area Under the Curve', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state area under the curve (AUC) of zidovudine (ZDV)'}, {'measure': 'Plasma Clearance of Zidovudine', 'timeFrame': '0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry', 'description': 'Steady-state plasma clearance (CL/F) of Zidovudine (ZDV)'}], 'secondaryOutcomes': [{'measure': 'Minimum Trough Concentration (Ctrough) of Lopinavir', 'timeFrame': 'Measured 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 4, 8, 12, 16, 24, 36 and 48 weeks following study entry', 'description': 'Count (%) of participants with minimum trough concentration (Ctrough) of steady-state Lopinavir \\>= 1 ug/mL'}, {'measure': 'Free Fraction of LPV at Hour 2 Post Dose', 'timeFrame': 'Weeks 1, 12 and 24', 'description': 'Free fraction of steady-state lopinavir at 2 hours post dose'}, {'measure': 'Change in HIV Viral Load From Baseline', 'timeFrame': 'Weeks 0, 12, 24, 36 and 48', 'description': 'Change from baseline in plasma HIV RNA viral load'}, {'measure': 'HIV Viral Load <400 Copies/mL', 'timeFrame': 'Baseline and weeks 12, 24, and 48', 'description': 'Count (%) of participants with plasma HIV RNA viral load \\<400 copies/mL'}, {'measure': 'Change in CD4 Percent', 'timeFrame': 'Weeks 0, 12, 24, 36 and 48', 'description': 'Change in CD4 percent from baseline'}, {'measure': 'Change in WHO Weight-for-height Z-score', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Change in WHO weight-for-height Z-score from entry. A Z-score indicates the number of standard deviations the measurement is away from the mean. A Z-score of 0 is equal to the mean of the reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. The reference population was determined by the World Health Organization for children from 0 up to 5 years.'}, {'measure': 'Change in Mid-upper Arm Circumference', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Change in mid-upper arm circumference (MUAC) from entry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Children', 'HAART', 'Malnourished'], 'conditions': ['HIV Positive', 'Malnourished']}, 'referencesModule': {'references': [{'pmid': '33464021', 'type': 'RESULT', 'citation': 'Owor M, Tierney C, Ziemba L, Browning R, Moye J, Graham B, Reding C, Costello D, Norman J, Wiesner L, Hughes E, Whalen ME, Purdue L, Mmbaga BT, Kamthunzi P, Kawalazira R, Nathoo K, Bradford S, Coletti A, Aweeka F, Musoke P. Pharmacokinetics and Safety of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in HIV-infected Children With Severe Acute Malnutrition in Sub-Saharan Africa: IMPAACT Protocol P1092. Pediatr Infect Dis J. 2021 May 1;40(5):446-452. doi: 10.1097/INF.0000000000003055.'}, {'pmid': '37919816', 'type': 'DERIVED', 'citation': 'Bwakura-Dangarembizi M, Ziemba L, Tierney C, Reding C, Bone F, Bradford S, Costello D, Browning R, Moye J, Vhembo T, Ngocho JS, Mallewa M, Chinula L, Musoke P, Owor M. Micronutrients and nutritional status among children living with HIV with and without severe acute malnutrition: IMPAACT P1092. BMC Nutr. 2023 Nov 2;9(1):121. doi: 10.1186/s40795-023-00774-1.'}], 'seeAlsoLinks': [{'url': 'https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables', 'label': 'Signs/symptoms, laboratory events, and diagnoses were graded using the Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events, Corrected Version 2.0, November 2014.'}, {'url': 'http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}]}, 'descriptionModule': {'briefSummary': 'Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to weight ratio in severely malnourished children could also place them at higher risk of under dosing compared to children with mild to moderate malnutrition. However, limited data are available on the pharmacokinetics of ARVs in severely malnourished children. This study addressed this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children living with HIV, compared to children with normal nutrition to mild malnutrition living with HIV.', 'detailedDescription': "P1092 was a prospective, non-randomized Phase IV open label study of antiretroviral drugs zidovudine (ZDV), lamivudine (3TC), and ritonavir boosted lopinavir (LPV/r) in children living with HIV aged 6 to less than 36 months grouped by nutritional status. The study's primary objectives were to characterize the pharmacokinetics (PK), safety, and tolerability of antiretroviral (ARV) regimens in severely acute malnourished (SAM) children following the initiation of nutritional rehabilitation and compare results to mildly malnourished or normally nourished children in order to determine if current recommended doses are optimal in severely malnourished children.\n\nTwo cohorts of children were enrolled based on nutritional status at screening: severely acute malnourished children and children with mild malnutrition or normal nutrition (non-SAM cohort). SAM participants were recruited from nutritional rehabilitation clinics while non-SAM participants were enrolled from HIV treatment centers. SAM participants were required to complete a 10 to 18 day nutritional rehabilitation program before entering the study. A World Health Organization (WHO, 2013) approach to management of SAM was used. All participants were to receive an antiretroviral regimen of ZDV+3TC+LPV/r. ARVs were dosed based on WHO weight band dosing and were to be administered twice per day in a pediatric liquid formulation. ZDV was allowed to be replaced with abacavir at the discretion of the site investigator/clinician in cases of grade 3 or higher hematologic toxicity on a ZDV-inclusive regimen or ZDV intolerance. Participants were followed for 48 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of HIV-1 infection defined as positive results from two samples collected at different time points, using protocol-specified tests\n* Meets WHO classification for severe malnutrition, normal nutrition status, or mild malnutrition\n* Eligible for HAART defined by WHO 2013 pediatric guidelines\n* Parent or legal guardian able and willing to provide signed informed consent, remain within the study area during the study period and agree to have subject followed at the clinical site\n* Qualifying hematology and chemistry laboratory values obtained from specimens collected within the study-specific screening period\n* For severely malnourished children: An inpatient in a nutrition rehabilitation unit. Clinical improvement after 10-18 days on nutrition rehabilitation defined as: Appetite returned and eating better - child shows interest in food even if does not complete amount given:\n* No further weight loss\n* Normalized sodium and potassium defined as severity grade 1 or lower\n* No evidence of cardiac failure\n* Loss of apathy and starting to play\n* No hypothermia or pyrexia - temperature stable at \\>35.0 to \\<38.0° C (non-axillary) or \\>34.4 to \\<37.4° C (axillary)\n\nFor children with normal - mild malnutrition, clinical stability will be indicated by:\n\n* Good appetite\n* Normalized sodium and potassium defined as severity grade 1 or lower\n* No hypothermia or pyrexia - temperature stable at \\>35.0 to \\<38.0° C (non-axillary) or \\>34.4 to \\<37.4° C (axillary)\n\nExclusion Criteria:\n\n* Edematous malnutrition at the time of study entry\n* ≥ Grade 3 respiratory distress or presence of cardio respiratory compromise within 3 days prior to entry\n* Chemotherapy for malignancy\n* Acute infection for which the child has received appropriate antimicrobial treatment for \\<5 days\n* Tuberculosis disease\n* Clinic hepatitis as evidenced by jaundice and hepatomegaly\n* Taking any disallowed medications\n* Any condition, situation, or clinical finding that in the opinion of the investigator would place the child at an unacceptable level of risk for injury, or render the child/caregiver(s) unable to meet the requirements of the study, interfere with study participation, or in the interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT01818258', 'briefTitle': 'IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children', 'organization': {'class': 'NETWORK', 'fullName': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group'}, 'officialTitle': 'IMPAACT 1092: Phase IV Evaluation Of The Steady State Pharmacokinetics Of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected Children', 'orgStudyIdInfo': {'id': 'IMPAACT P1092'}, 'secondaryIdInfos': [{'id': 'U01AI068632', 'link': 'https://reporter.nih.gov/quickSearch/U01AI068632', 'type': 'NIH'}, {'id': '11689', 'type': 'OTHER', 'domain': 'DAIDS Study ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Severe Malnutrition', 'description': 'ZDV+3TC+LPV/r Zidovudine (ZDV, Retrovir®) 10 mg/ml oral syrup administered twice daily at WHO weight band dose for 48 weeks; Lamivudine (Epivir®, 3TC) 10 mg/ml for oral solution administered twice daily at WHO weight band dose for 48 weeks; Lopinavir/ritonavir (Kaletra®, LPV/r) 80/20 mg/ml oral solution administered twice daily at the WHO weight band dose for 48 weeks', 'interventionNames': ['Drug: ZDV+3TC+LPV/r']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Nutrition/Mild Malnutrition', 'description': 'ZDV+3TC+LPV/r Zidovudine (ZDV, Retrovir®) 10 mg/ml oral syrup administered twice daily at WHO weight band dose for 48 weeks; Lamivudine (Epivir®, 3TC) 10 mg/ml for oral solution administered twice daily at WHO weight band dose for 48 weeks; Lopinavir/ritonavir (Kaletra®, LPV/r) 80/20 mg/ml oral solution administered twice daily at the WHO weight band dose for 48 weeks', 'interventionNames': ['Drug: ZDV+3TC+LPV/r']}], 'interventions': [{'name': 'ZDV+3TC+LPV/r', 'type': 'DRUG', 'otherNames': ['Zidovudine', 'Retrovir', 'Lamivudine', 'Epivir', 'Lopinavir/ritonavir', 'Kaletra'], 'armGroupLabels': ['Normal Nutrition/Mild Malnutrition', 'Severe Malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Blantyre CRS (30301)', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Malawi CRS (12001)', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Kilimanjaro Christian Medical Centre (5118)', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Makerere University-Johns Hopkins University (MUJHU) Research Collaboration (30293)', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Harare Family Care (31890)', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Maxensia O Owor, MBChB, MMED, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.\n* For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.\n* By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}