Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT02075593
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2014-02-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D012897', 'term': 'Slow 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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}, {'id': 'C106538', 'term': 'abacavir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328', 'description': 'Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.', 'eventGroups': [{'id': 'EG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '55.045', 'groupId': 'OG000', 'lowerLimit': '37.918', 'upperLimit': '79.907'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '42.473', 'groupId': 'OG000', 'lowerLimit': '27.613', 'upperLimit': '65.330'}]}]}, {'title': '8-12 Weeks postpartum', 'categories': [{'measurements': [{'value': '78.917', 'groupId': 'OG000', 'lowerLimit': '53.195', 'upperLimit': '117.075'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Micrograms*hours per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population consists of all participants in the Safety Population (comprised of all participants \\[pregnant women\\] who received at least one dose of study treatment) who had at least 1 non-missing PK assessment.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '4.420', 'groupId': 'OG000', 'lowerLimit': '2.906', 'upperLimit': '6.724'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '3.424', 'groupId': 'OG000', 'lowerLimit': '2.038', 'upperLimit': '5.753'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '5.578', 'groupId': 'OG000', 'lowerLimit': '3.866', 'upperLimit': '8.049'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '930.1', 'groupId': 'OG000', 'lowerLimit': '562.0', 'upperLimit': '1539.3'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '657.5', 'groupId': 'OG000', 'lowerLimit': '266.1', 'upperLimit': '1624.4'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '2154.7', 'groupId': 'OG000', 'lowerLimit': '901.4', 'upperLimit': '5150.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '0.739', 'groupId': 'OG000', 'lowerLimit': '0.484', 'upperLimit': '1.130'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '0.952', 'groupId': 'OG000', 'lowerLimit': '0.559', 'upperLimit': '1.620'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '0.464', 'groupId': 'OG000', 'lowerLimit': '0.062', 'upperLimit': '3.476'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Liters per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '9.665', 'groupId': 'OG000', 'lowerLimit': '6.651', 'upperLimit': '14.044'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '12.326', 'groupId': 'OG000', 'lowerLimit': '7.878', 'upperLimit': '19.285'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '6.326', 'groupId': 'OG000', 'lowerLimit': '0.048', 'upperLimit': '833.336'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Half-life (T1/2) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '9.215', 'spread': '1.8968', 'groupId': 'OG000'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '9.401', 'spread': '3.0322', 'groupId': 'OG000'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '9.699', 'spread': '3.0427', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 32 of study', 'description': 'Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'ALT, Baseline (Day 1), n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '5.56', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '4.43', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '17.21', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '3.16', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '7.27', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '15.56', 'groupId': 'OG000'}]}]}, {'title': 'AST, Baseline (Day 1), n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.8', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '6.18', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.8', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '3.30', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.0', 'spread': '8.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including ALT and AST.', 'unitOfMeasure': 'International units per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Chemistry Parameters: ALT and AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'ALT, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '6.03', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '11.79', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.30', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.56', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '14.85', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.43', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.10', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.37', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '8.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including ALT and AST. 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Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameters: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '10.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'spread': '7.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '4.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.8', 'spread': '6.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '4.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '8.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Grams per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'PRIMARY', 'title': 'Absolute Values of the Hematology Parameters: Leukocytes and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Leukocytes, Baseline (Day 1), n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.48', 'spread': '1.415', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.88', 'spread': '2.095', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.43', 'spread': '1.959', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.15', 'spread': '2.053', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.23', 'spread': '1.821', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.03', 'spread': '2.848', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.60', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.85', 'spread': '0.636', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Baseline (Day 1), n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '204.8', 'spread': '37.03', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '200.5', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '220.8', 'spread': '16.07', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '195.5', 'spread': '25.38', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '198.0', 'spread': '10.80', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '216.5', 'spread': '10.91', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '250.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '206.0', 'spread': '24.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets.', 'unitOfMeasure': 'Giga cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameters: Leukocytes and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Leukocytes, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '1.817', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '2.047', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '1.173', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '1.654', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.55', 'spread': '2.340', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.061', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '39.09', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '33.44', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '39.08', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '47.16', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '45.49', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 24, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '50.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Giga cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'PRIMARY', 'title': 'Number of Participants (Pregnant Women) Who Discontinued the Treatment Due to Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 292', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment'}, {'type': 'PRIMARY', 'title': 'Number of Participants (Pregnant Women) Demonstrated Congenital Malformations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Data for participants (pregnant women) demonstrated congenital malformations was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '3.508', 'spread': '1.7082', 'groupId': 'OG000'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '2.729', 'spread': '0.4877', 'groupId': 'OG000'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '4.242', 'spread': '2.0522', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Pre-dose Plasma Concentration (C0) for Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Trimester 2 (Weeks 18-26 of pregnancy)', 'categories': [{'measurements': [{'value': '666.9', 'groupId': 'OG000', 'lowerLimit': '149.5', 'upperLimit': '2974.6'}]}]}, {'title': 'Trimester 3 (Weeks 30-36 of pregnancy)', 'categories': [{'measurements': [{'value': '1084.6', 'groupId': 'OG000', 'lowerLimit': '676.7', 'upperLimit': '1738.3'}]}]}, {'title': '8-12 Weeks Postpartum', 'categories': [{'measurements': [{'value': '1225.0', 'groupId': 'OG000', 'lowerLimit': '522.8', 'upperLimit': '2870.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'At 3 hours post dose in Trimester 2', 'categories': [{'measurements': [{'value': '7.856', 'groupId': 'OG000', 'lowerLimit': '4.370', 'upperLimit': '14.122'}]}]}, {'title': 'At 3 hours post dose in Trimester 3', 'categories': [{'measurements': [{'value': '7.371', 'groupId': 'OG000', 'lowerLimit': '4.594', 'upperLimit': '11.827'}]}]}, {'title': 'At 3 hours post dose 8-12 Weeks postpartum', 'categories': [{'measurements': [{'value': '6.898', 'groupId': 'OG000', 'lowerLimit': '4.360', 'upperLimit': '10.914'}]}]}, {'title': 'At 24 hours post dose in Trimester 2', 'categories': [{'measurements': [{'value': '1.798', 'groupId': 'OG000', 'lowerLimit': '0.887', 'upperLimit': '3.644'}]}]}, {'title': 'At 24 hours post dose in Trimester 3', 'categories': [{'measurements': [{'value': '2.065', 'groupId': 'OG000', 'lowerLimit': '1.229', 'upperLimit': '3.471'}]}]}, {'title': 'At 24 hours post dose 8-12 Weeks postpartum', 'categories': [{'measurements': [{'value': '2.881', 'groupId': 'OG000', 'lowerLimit': '1.503', 'upperLimit': '5.520'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Cord plasma concentration', 'categories': [{'measurements': [{'value': '1436.0', 'spread': '1287.43', 'groupId': 'OG000'}]}]}, {'title': 'Maternal plasma concentration', 'categories': [{'measurements': [{'value': '1806.3', 'spread': '1125.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Blood samples were collected at the time of delivery for PK analysis of dolutegravir.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Participants with genotypic resistance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Participants with phenotypic resistance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 32 of study', 'description': 'Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed (ITT-E) Population includes all participants (pregnant women) who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants (Pregnant Women) With Live Birth Outcome Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Vaginal Birth', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Planned Caesarean Section', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled Caesarean Section', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Preterm Delivery', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Gestational Age of Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '1.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At birth', 'description': "Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented.", 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Neonatal Length and Head Circumference at Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.'}], 'classes': [{'title': 'Neonatal Length', 'categories': [{'measurements': [{'value': '51.5', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'Neonatal Head Circumference', 'categories': [{'measurements': [{'value': '34.9', 'spread': '1.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At birth', 'description': 'Data for neonatal length and head circumference at birth are reported.', 'unitOfMeasure': 'Centimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Neonatal Weight at Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3262.5', 'spread': '731.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At birth', 'description': 'Data for neonatal weight at birth has been reported.', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Infants by Their Weight Categories at Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.'}], 'classes': [{'title': 'LGA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AGA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'SGA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At birth', 'description': 'Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Infant', 'description': 'This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.'}], 'classes': [{'title': '1 Minute, Score 0 to 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 Minute, Score 7 to 10', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '5 Minute, Score 0 to 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '5 Minute, Score 7 to 10', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 and 5 minutes after birth', 'description': 'APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Percentage of participants (pregnant women) with plasma HIV-1 RNA \\<50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Percentage of participants (pregnant women) with plasma HIV-1 RNA \\<400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Baseline (Day 1), n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '476.3', 'spread': '123.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '569.5', 'spread': '238.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '569.8', 'spread': '296.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '575.0', 'spread': '331.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '626.8', 'spread': '270.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '791.5', 'spread': '524.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '874.5', 'spread': '516.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '488.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '677.5', 'spread': '40.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of CD4+ T cell counts using cytometry.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T Cell Counts by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Week 4, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '124.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.5', 'spread': '174.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.8', 'spread': '208.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '150.5', 'spread': '148.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '315.3', 'spread': '402.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '353.0', 'spread': '332.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': 'NA', 'comment': 'NA indicates that standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '246.0', 'spread': '97.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants (Pregnant Women) With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 32 of study', 'description': 'Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 292 Weeks', 'description': 'Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Infants Born to Pregnant Women Who Received at Least One Dose of Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This is a single arm open-label study in women who became pregnant while participating in study ING117172 (NCT01910402).', 'preAssignmentDetails': 'In this study, 4 pregnant women were enrolled. Participant flow data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DTG/ABC/3TC - Mother', 'description': 'Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '5.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian/European heritage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-19', 'size': 1703540, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-08T03:25', 'hasProtocol': True}, {'date': '2021-10-05', 'size': 12716962, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-05T08:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2020-08-05', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2014-02-27', 'dispFirstSubmitQcDate': '2020-08-13', 'resultsFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2014-02-27', 'dispFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-25', 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir', 'timeFrame': '24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Apparent Oral Clearance (CL/F) for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Half-life (T1/2) for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin', 'timeFrame': 'Up to Week 32 of study', 'description': 'Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented.'}, {'measure': 'Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including ALT and AST.'}, {'measure': 'Change From Baseline in Chemistry Parameters: ALT and AST', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.'}, {'measure': 'Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.'}, {'measure': 'Absolute Values of the Hematology Parameters: Hemoglobin', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including hemoglobin.'}, {'measure': 'Change From Baseline in Hematology Parameters: Hemoglobin', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.'}, {'measure': 'Absolute Values of the Hematology Parameters: Leukocytes and Platelets', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets.'}, {'measure': 'Change From Baseline in Hematology Parameters: Leukocytes and Platelets', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.'}, {'measure': 'Number of Participants (Pregnant Women) Who Discontinued the Treatment Due to Adverse Events (AE)', 'timeFrame': 'Up to Week 292', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented.'}, {'measure': 'Number of Participants (Pregnant Women) Demonstrated Congenital Malformations', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Data for participants (pregnant women) demonstrated congenital malformations was reported.'}, {'measure': 'Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades', 'timeFrame': 'Up to 292 Weeks', 'description': 'Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required.'}], 'secondaryOutcomes': [{'measure': 'Time to Cmax (Tmax) for Dolutegravir', 'timeFrame': 'Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Pre-dose Plasma Concentration (C0) for Dolutegravir', 'timeFrame': 'Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir', 'timeFrame': 'At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum', 'description': 'Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.'}, {'measure': 'Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Blood samples were collected at the time of delivery for PK analysis of dolutegravir.'}, {'measure': 'Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria', 'timeFrame': 'Up to Week 32 of study', 'description': 'Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays.'}, {'measure': 'Number of Participants (Pregnant Women) With Live Birth Outcome Categories', 'timeFrame': 'At delivery (up to Week 40 of pregnancy)', 'description': 'Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery.'}, {'measure': 'Gestational Age of Infants', 'timeFrame': 'At birth', 'description': "Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented."}, {'measure': 'Neonatal Length and Head Circumference at Birth', 'timeFrame': 'At birth', 'description': 'Data for neonatal length and head circumference at birth are reported.'}, {'measure': 'Neonatal Weight at Birth', 'timeFrame': 'At birth', 'description': 'Data for neonatal weight at birth has been reported.'}, {'measure': 'Number of Infants by Their Weight Categories at Birth', 'timeFrame': 'At birth', 'description': 'Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight.'}, {'measure': 'Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth', 'timeFrame': '1 and 5 minutes after birth', 'description': 'APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented.'}, {'measure': 'Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit', 'timeFrame': 'At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Percentage of participants (pregnant women) with plasma HIV-1 RNA \\<50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.'}, {'measure': 'Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit', 'timeFrame': 'At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Percentage of participants (pregnant women) with plasma HIV-1 RNA \\<400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA.'}, {'measure': 'Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit', 'timeFrame': 'At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of CD4+ T cell counts using cytometry.'}, {'measure': 'Change From Baseline in CD4+ T Cell Counts by Visit', 'timeFrame': 'Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study', 'description': 'Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.'}, {'measure': 'Number of Participants (Pregnant Women) With Disease Progression', 'timeFrame': 'Up to Week 32 of study', 'description': 'Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dolutegravir/abacavir/lamivudine fixed dose combination', 'pregnant women', 'once daily', 'antiretroviral therapy-naive', 'HIV-1 Infection', 'integrase inhibitor'], 'conditions': ['Infection, Human Immunodeficiency Virus', 'HIV Infections', 'Arthralgia']}, 'descriptionModule': {'briefSummary': 'In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing the risk for maternal disease progression), but also to reduce the risk of maternal-fetal transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study also offers the first opportunity to investigate the impact of pregnancy on DTG pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of women that will be enrolled into this study cannot be established a priori, as unintended pregnancies cannot be determined in advance. The maximum number of women would include all of those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended pregnancies in all of these women would not be anticipated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV infected females participating in ING117172 on the DTG/ABC/3TC treatment arm who became pregnant with a singleton and have not met any safety or confirmed virologic withdrawal criteria.\n* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.\n* Willingness and intent to continue pregnancy\n* Willingness to continue to receive DTG/ABC/3TC FDC.\n* Willingness to enter the Antiretroviral Pregnancy Registry.\n* Willingness to share medical information about herself and her infant for collection of delivery and infant outcomes as it relates to this study.\n* Subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.\n\nExclusion Criteria:\n\n* History of allergy/sensitivity to DTG, ABC and/or 3TC.\n* History of severe pre-clampsia, eclampsia, or hemolysis, elevated liver enzymes and low platelet count (HELLP)\n* Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell levels \\<200 cells/millimeter\\^3.\n* Subjects with any degree of hepatic impairment.\n* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject.\n* Subjects who in the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.\n* Subjects with evidence of ongoing hepatitis B infection at screening, or anticipated need for Hepatitis C Virus therapy during the study.\n* Treatment with any of the following agents within 28 days of Baseline: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses.\n* Subjects enrolled in France: the subject has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study.\n* Any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, high density lipoprotein \\[HDL\\] cholesterol, low density lipoprotein \\[LDL\\] cholesterol). A single repeat test is allowed during the Screening period to verify a result.\n* Any acute laboratory abnormality observed in ING117172 or in any Screening laboratory assessments for ING200336, which, in the opinion of the Investigator, would preclude the subject's participation in the study.\n* Hyperbilirubinemia of unknown etiology.\n* Confirmed (with no more than 1 repeat evaluation) Grade \\>= 2 urine protein (dipstick), serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase at the time of the screening lab.\n* Subject has Creatinine Clearance of \\<50 mL/minute via Cockroft-Gault method at the time of the screening visit"}, 'identificationModule': {'nctId': 'NCT02075593', 'briefTitle': 'ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'ING200336: A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women', 'orgStudyIdInfo': {'id': '200336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTG/ABC/3TC', 'description': 'All subjects will be administered DTG 50 milligrams (mg)/ABC 600 mg/3TC 300 mg FDC tablet once daily, with or without food.', 'interventionNames': ['Drug: DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets']}], 'interventions': [{'name': 'DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets', 'type': 'DRUG', 'description': 'The DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablet is a purple, oval, biconvex tablets. The tablet contains 52.6 mg DTG sodium which is equivalent to 50 mg DTG free acid, 702 mg ABC sulphate which is equivalent to 600 mg ABC and 300 mg 3TC.', 'armGroupLabels': ['DTG/ABC/3TC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '302040', 'city': 'Oryol', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.96879, 'lon': 36.0791}}, {'zip': '196645', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}