Viewing Study NCT01172535

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 10:35 PM

Ignite Modification Date: 2025-12-28 @ 10:00 AM

Study NCT ID: NCT01172535

Status: COMPLETED

Last Update Posted: 2021-11-05

First Post: 2010-07-28

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'interventionBrowseModule': {'meshes': [{'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mallen@fhi360.org', 'phone': '(919) 405-1429', 'title': 'Melissa Allen, Director, IMPAACT Operations Center', '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 seven (7) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From entry until off-study (week 24)', 'description': 'Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.', 'eventGroups': [{'id': 'EG000', 'title': 'LPV/r', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.', 'otherNumAtRisk': 97, 'otherNumAffected': 96, 'seriousNumAtRisk': 97, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctival pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Immune reconstitution inflammatory syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Amylase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Use of accessory respiratory muscles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Immune reconstitution inflammatory syndrome associated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperamylasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000', 'lowerLimit': '177', 'upperLimit': '217'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants having complete pharmacokinetics data at week 4'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration of Lopinavir/Ritonavir (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.25', 'groupId': 'OG000', 'lowerLimit': '10.24', 'upperLimit': '12.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants having complete pharmacokinetics data at week 4'}, {'type': 'PRIMARY', 'title': 'Minimum Concentration of Lopinavir/Ritonavir (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '1.52', 'upperLimit': '4.02'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants having complete pharmacokinetics data at week 4'}, {'type': 'PRIMARY', 'title': 'Clearance of Lopinavir/Ritonavir (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling', 'unitOfMeasure': 'L/h/kg', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants having complete pharmacokinetics data at week 4'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants With an AUC of Less Than 10% of Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Proportion of participants with an AUC less that 10% of adults (AUC0-24 \\<104 mcg\\*hr/mL)', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with complete pharmacokinetics data at week 4'}, {'type': 'SECONDARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 4', 'description': 'Participants bringing medication to be measured at study week 4'}, {'id': 'OG001', 'title': 'Week 12', 'description': 'Participants bringing medication to be measured at study week 12'}, {'id': 'OG002', 'title': 'Week 24', 'description': 'Participants bringing medication to be measured at study week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.10'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.01'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.91', 'upperLimit': '1.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at week 4, week 12, and study completion (week 24)', 'description': 'Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)', 'unitOfMeasure': 'Proportion of expected doses taken', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants bringing medication to be measured at the study visit'}, {'type': 'SECONDARY', 'title': 'Treatment Efficacy (HIV Viral Load)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at entry and study completion (week 24)', 'description': 'Having HIV viral load \\<400 copies/mL at the week 24 visit', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data from both study entry and the week 24 study visit'}, {'type': 'SECONDARY', 'title': 'Treatment Efficacy (CD4%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '0.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at entry and study completion (week 24)', 'description': 'Having CD4%≥25 at the week 24 visit.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data from both study entry and the week 24 study visit'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Adverse Events of Grade 3 or 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at study visits through end of study (weeks 2, 4, 12, 24)', 'description': 'Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants Tolerating LPV/r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at study completion (week 24)', 'description': 'Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ineligible at study entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unwilling to adhere to study requirement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'There were 97 participants enrolled from 19 clinical sites in four countries. There were 57 participants on the liquid formulation and 40 on tablet. Accrual took place from May 20, 2011 through June 19, 2013.', 'preAssignmentDetails': 'HIV-infected infants and children ≥3 to \\<25 kg had to be LPV/r-treatment naïve. Children ≥10 kg had to demonstrate ability and willingness to swallow tablets. Participants were stratified by weight and drug formulation (liquid vs. tablet).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '6.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV RNA (copies/mL) at study entry', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'BG000', 'lowerLimit': '4.6', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4% at study entry', 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'groupId': 'BG000', 'lowerLimit': '15.8', 'upperLimit': '29.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of total lymphocytes', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'All participants enrolled in the study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2010-07-28', 'resultsFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-16', 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir'}, {'measure': 'Maximum Concentration of Lopinavir/Ritonavir (Cmax)', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling'}, {'measure': 'Minimum Concentration of Lopinavir/Ritonavir (Cmin)', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling'}, {'measure': 'Clearance of Lopinavir/Ritonavir (CL/F)', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling'}, {'measure': 'Proportion of Participants With an AUC of Less Than 10% of Adults', 'timeFrame': 'Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose', 'description': 'Proportion of participants with an AUC less that 10% of adults (AUC0-24 \\<104 mcg\\*hr/mL)'}, {'measure': 'Number of Participants Experiencing Adverse Events of Grade 3 or 4', 'timeFrame': 'Measured at study visits through end of study (weeks 2, 4, 12, 24)', 'description': 'Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death'}, {'measure': 'Proportion of Participants Tolerating LPV/r', 'timeFrame': 'Measured at study completion (week 24)', 'description': 'Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'Measured at week 4, week 12, and study completion (week 24)', 'description': 'Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)'}, {'measure': 'Treatment Efficacy (HIV Viral Load)', 'timeFrame': 'Measured at entry and study completion (week 24)', 'description': 'Having HIV viral load \\<400 copies/mL at the week 24 visit'}, {'measure': 'Treatment Efficacy (CD4%)', 'timeFrame': 'Measured at entry and study completion (week 24)', 'description': 'Having CD4%≥25 at the week 24 visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lopinavir/ritonavir', 'Pediatric dosing', 'World Health Organization'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': "Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical in busy clinical settings. To address this, the World Health Organization (WHO) has released a simplified dosing table based on infant weight bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants when dosed according to the new WHO guidelines.", 'detailedDescription': "Because of previous exposure to nevirapine or other non-nucleoside reverse transcriptase inhibitors (NNRTIs), either by direct treatment or through their mothers in pregnancy, infants must often receive an alternate antiretroviral regimen that includes LPV/r. Dosing of LPV/r is currently based on a child's specific weight, and calculations of proper dosages are often too complicated to be practical in busy clinics, particularly those in limited resource settings. In order to simplify medication delivery and reduce prescribing errors, the WHO has released a dosing schedule for LPV/r based on groupings of infants and children by weight. This study will evaluate the pharmacokinetics, safety, and tolerance of LPV/r dosed according to these guidelines. The following strata were used to guide accrual:\n\nNumber of Participants to be Enrolled by Weight Band:\n\n3-4.9 kg: 11 liquid\n\n5-6.9 kg: 11 liquid\n\n7-9.9 kg: 17 liquid\n\n10-16.9 kg: 11 liquid, 22 tablet\n\n17-19.9 kg: 11 tablet\n\n20-24.9 kg: 11 tablet\n\nParticipation in this study will last 6 months. Infant participants and their caretakers will need to attend study visits at entry and Weeks 2, 4, 12, and 24. At entry, participants will be given LPV/r either in liquid or tablet form, depending on whether they can swallow pills. Dosing will be calculated using the WHO schedule. At all study visits, participants will undergo a physical exam and caretakers will be asked about how well the child is taking the study medications. In addition, at Weeks 4, 12, and 24, blood samples will be taken from the participant to determine health and levels of the medication in the body. The visit on Week 4 will also require pharmacokinetic testing, which means the child will need to be monitored at the hospital for 12 hours and complete six additional blood drawls. All other study visits will last 1 to 2 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Weight equal to or greater than 3 kg, but less than 25 kg, at the time of enrollment\n* Confirmed diagnosis of HIV-1 infection\n* Lopinavir/ritonavir (LPV/r)-treatment naïve and LPV/r-treatment eligible as defined by country-specific guidelines or the WHO pediatric treatment guidelines and confirmed by investigator\n* Willingness to take two nucleoside reverse transcriptase inhibitos (NRTIs), in accordance with appropriate national or international treatment guidelines\n* Demonstrated ability and willingness to swallow tablets for children larger than 10 kg. This can be assessed before inclusion (for example, a test trial with similar size solid tablet such as tic-tac).\n* Participants in the weight band between 10 and 16.9 kg that are unable to swallow tablets will receive liquid formulation\n* Parent or legal guardian able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Planned concurrent use of non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, or an entry inhibitor\n* Planned concurrent protease inhibitor (PI) use, other than LPV/r\n* Prior treatment with LPV/r. Prior treatment with other PIs is allowed.\n* Results of certain laboratory tests indicating adverse events of Grade 3 or greater\n* Results of a lipase test indicating adverse event of Grade 2 or greater or clinical evidence of pancreatitis within 30 days prior to study entry\n* Tuberculosis co-treatment with rifampicin-containing regimen\n* Treatment with any enzyme-inducing antiepileptic drugs, such as henobarbital, phenytoin or carbamazepine\n* Clinical condition requiring the use of a prohibited medication (see protocol for more details)\n* Clinically unstable child requiring acute treatment for a serious opportunistic infection\n* Chemotherapy for active malignancy\n* Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participation in this study\n* Treatment with experimental drugs for any indication within 30 days prior to study entry\n* Known history of cardiac conduction abnormality and/or underlying structural heart disease, including congenital long QT"}, 'identificationModule': {'nctId': 'NCT01172535', 'briefTitle': 'A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines', 'nctIdAliases': ['NCT01338038'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines', 'orgStudyIdInfo': {'id': 'P1083'}, 'secondaryIdInfos': [{'id': '10787', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'IMPAACT P1083'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lopinavir/ritonavir', 'description': 'Participants will receive lopinavir/ritonavir in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.', 'interventionNames': ['Drug: Lopinavir/ritonavir']}], 'interventions': [{'name': 'Lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['Kaletra', 'LPV/r'], 'description': 'Heat-stable tablets of 100 mg lopinavir, 25 mg ritonavir, or liquid formulation of 80 mg lopinavir, 20 mg ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines', 'armGroupLabels': ['Lopinavir/ritonavir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0672', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, UC San Diego CRS', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Denver NICHD CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center Ped. HIV Program NICHD CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'SOM Federal University Minas Gerais Brazil NICHD CRS', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hosp. Santa Casa Porto Alegre Brazil NICHD CRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20221-903', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Federal dos Servidores do Estado NICHD CRS', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '21941-612', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '26030', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hosp. Geral De Nova Igaucu Brazil NICHD CRS', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01246-900', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '14049-900', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Univ. of Sao Paulo Brazil NICHD CRS', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Shandukani CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7505', 'city': 'Tygerberg', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Family Clinical Research Unit (FAM-CRU) CRS'}, {'zip': '10220', 'city': 'Saimai', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Bhumibol Adulyadej Hosp. CRS'}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkoknoi', 'country': 'Thailand', 'facility': 'Siriraj Hospital Mahidol University CRS', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '22000', 'city': 'Chanthaburi', 'country': 'Thailand', 'facility': 'Prapokklao Hosp. CRS', 'geoPoint': {'lat': 12.60961, 'lon': 102.10447}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '57000', 'city': 'Chiangrai', 'country': 'Thailand', 'facility': 'Chiangrai Prachanukroh Hospital CRS'}, {'zip': '2000', 'city': 'Chon Buri', 'country': 'Thailand', 'facility': 'Chonburi Hosp. CRS', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'zip': '56000', 'city': 'Phayao', 'country': 'Thailand', 'facility': 'Phayao Provincial Hosp. CRS', 'geoPoint': {'lat': 19.19203, 'lon': 99.87883}}], 'overallOfficials': [{'name': 'Jorge A. Pinto, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}