Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 6:14 PM
Study NCT ID:
NCT05631093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2022-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
Sponsor:
Organization:
Raw JSON
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Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse events up to 48 weeks.', 'description': 'All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).', 'otherNumAtRisk': 366, 'deathsNumAtRisk': 368, 'otherNumAffected': 123, 'seriousNumAtRisk': 366, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 73, 'seriousNumAtRisk': 185, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 45, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cervix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.58', 'ciLowerLimit': '-7.81', 'ciUpperLimit': '-0.77', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.', 'nonInferiorityComment': 'Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and had data for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Adverse Events (AEs) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '2.8', 'estimateComment': 'Difference in percentage versus (vs) Baseline ART was based on Miettinen \\& Nurminen method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted."}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an AE Leading to Discontinuation of Study Intervention at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '0.2', 'estimateComment': 'Difference in percentage versus (vs) Baseline ART was based on Miettinen \\& Nurminen method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted."}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}, {'value': '95.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-3.49', 'ciUpperLimit': '4.21', 'estimateComment': 'Difference in percentage versus (vs) Baseline ART was based on Miettinen \\& Nurminen method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted."}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and had data for analysis excluding participants who had at least one major deviation that may substantially affect the results of the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}, {'value': '91.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciPctValue': '95', 'paramValue': '3.75', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '8.89', 'estimateComment': 'Difference in percentage versus (vs) Baseline ART was based on Miettinen \\& Nurminen method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted."}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and had data for analysis excluding participants who had at least one major deviation that may substantially affect the results of the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Participants With HIV-1 RNA <200 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Mean Change of Plasma Cluster of Differentiation 4 (CD4+) T-Cell Count From Baseline Day 1 to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.41', 'groupId': 'OG000', 'lowerLimit': '-12.11', 'upperLimit': '22.94'}, {'value': '18.22', 'groupId': 'OG001', 'lowerLimit': '-11.84', 'upperLimit': '48.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciPctValue': '95', 'paramValue': '-15.43', 'ciLowerLimit': '-46.32', 'ciUpperLimit': '15.47', 'estimateComment': 'Difference in percentage versus (vs) Baseline ART was based on a cDLA model.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in mean change from baseline versus Baseline Antiretroviral Therapy (ART)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline at Day 1 and Week 48', 'description': 'Plasma CD4+ T-Cell Count was measured in cells/mm\\^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean change of plasma CD4+ T-Cell count from baseline to Week 48 is presented.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and who have baseline data.'}, {'type': 'SECONDARY', 'title': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Week 48 to Week 96', 'timeFrame': 'Baseline at Week 48 and Week 96', 'description': 'Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 48 to Week 144', 'timeFrame': 'Baseline at Week 48 and Week 144', 'description': 'Mean change from baseline at Week 48 in CD4+ T-cell count at Week 144. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 96', 'timeFrame': 'Baseline at Day 1 and Week 96', 'description': 'Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 144', 'timeFrame': 'Baseline at Day 1 and Week 144', 'description': 'Mean change from baseline at Day 1 in CD4+ T-cell count at Week 144. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'Participants with clinically significant confirmed viremia \\[2 consecutive occurences 4 weeks (+-1 week) apart of HIV-1 RNA \\>=200 copies/mL at any time during the study\\] or who discontinue study intervention for another reason with HIV-1 RNA \\>=200 copies/mL at the time of discontinuation met the criteria for post-baseline resistance testing. Participants with HIV-1 RNA \\>=400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Plasma samples were collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and virus susceptibility to study intervention. The percentage of participants in the resistance analysis subset with treatment-emergent resistance-associated substitutions to the study intervention is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA \\>=400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'title': 'PI-containing regimens (including PI- + InSTI-containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.10', 'groupId': 'OG000', 'lowerLimit': '-27.06', 'upperLimit': '12.86'}, {'value': '-2.75', 'groupId': 'OG001', 'lowerLimit': '-9.91', 'upperLimit': '4.41'}]}]}, {'title': 'non-PI- and non-InSTI-containing regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.07', 'groupId': 'OG000', 'lowerLimit': '-0.77', 'upperLimit': '10.91'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '-5.92', 'upperLimit': '6.50'}]}]}, {'title': 'InSTI-containing regimens (non-PI-containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '5.63'}, {'value': '-0.37', 'groupId': 'OG001', 'lowerLimit': '-5.02', 'upperLimit': '4.28'}]}]}], 'analyses': [{'pValue': '0.8340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.21', 'ciLowerLimit': '-24.91', 'ciUpperLimit': '20.49', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'PI-containing regimens (including PI- + InSTI-containing regimens)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}, {'pValue': '0.4250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.44', 'ciLowerLimit': '-5.08', 'ciUpperLimit': '11.97', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'non-PI- and non-InSTI-containing regimens', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}, {'pValue': '0.1618', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciPctValue': '95', 'paramValue': '3.72', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '8.95', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'InSTI-containing regimens (non-PI-containing regimens)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Low density lipoprotein cholesterol (LDL-C) at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and had baseline data and at least one post-baseline test result in the specified analysis window.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'OG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'classes': [{'title': 'PI-containing regimens (including PI- + InSTI-containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.80', 'groupId': 'OG000', 'lowerLimit': '-32.04', 'upperLimit': '8.44'}, {'value': '-2.75', 'groupId': 'OG001', 'lowerLimit': '-10.90', 'upperLimit': '5.40'}]}]}, {'title': 'non-PI- and non-InSTI-containing regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '11.97'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '-6.47', 'upperLimit': '7.35'}]}]}, {'title': 'InSTI-containing regimens (non-PI-containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '7.14'}, {'value': '3.29', 'groupId': 'OG001', 'lowerLimit': '-5.87', 'upperLimit': '12.44'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.02', 'ciLowerLimit': '-29.80', 'ciUpperLimit': '15.77', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'PI-containing regimens (including PI- + InSTI-containing regimens)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '13.21', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'non-PI- and non-InSTI-containing regimens', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '-6.83', 'ciUpperLimit': '8.87', 'estimateComment': 'The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.', 'groupDescription': 'InSTI-containing regimens (non-PI-containing regimens)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment difference versus baseline ART'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Non-HDL-C at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention and had baseline data and at least one post-baseline test result in the specified analysis window.'}, {'type': 'SECONDARY', 'title': 'Participants With One or More AEs at Week 96', 'timeFrame': 'Up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 96 is reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Participants With One or More AEs at Week 144', 'timeFrame': 'Up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 144 is reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 96', 'timeFrame': 'Up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 96 are reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 144', 'timeFrame': 'Up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 144 are reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With One or More AEs From Week 48 up to Week 96', 'timeFrame': 'Week 48 up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 96 is reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With One or More AEs From Week 48 up to Week 144', 'timeFrame': 'Week 48 up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 144 is presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 96', 'timeFrame': 'Week 48 up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 96 are reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 144', 'timeFrame': 'Week 48 up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 144 are reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'FG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '182'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adults living with human immunodeficiency virus-1 (HIV-1) receiving baseline antiretroviral therapy (ART) were enrolled.', 'preAssignmentDetails': 'Of the 553 participants randomly assigned in a 2:1 ratio to either Group 1: participants switched from baseline ART to doravirine (DOR)/islatravir (ISL) on Day 1 to Week 144; or Group 2: participants continued baseline ART until Week 48 then switch to DOR/ISL from Week 48 to Week 144, 551 participants received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Doravirine/Islatravir (DOR/ISL)', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'BG001', 'title': 'Baseline ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '49.8', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Antiretroviral (ART) Stratification at Randomization', 'classes': [{'title': 'PI-containing regimens (including PI- and InSTI-containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'InSTI-based regimens (non-PI containing regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}]}, {'title': 'All other non-PI- and non-InSTI containing regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were stratified into the following baseline ART regimen: (1) Protease inhibitor (PI)-containing regimens (including PI- and integrase strand transferase inhibitor \\[InSTI\\]-containing regimens); (2) InSTI-based regimens (non-PI containing regimens); (3) All other non-PI- and non-InSTI containing regimens.', 'unitOfMeasure': 'Count of Participants', 'populationDescription': 'All randomized participants who received study intervention.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-07', 'size': 3505862, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-29T08:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2022-11-18', 'resultsFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-11', 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With One or More Adverse Events (AEs) at Week 48', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported.'}, {'measure': 'Percentage of Participants With an AE Leading to Discontinuation of Study Intervention at Week 48', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Participants With HIV-1 RNA <200 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<200 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144', 'timeFrame': 'Week 144', 'description': 'HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \\<50 copies/mL. The percentage of participants with HIV-1 RNA \\<50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach.'}, {'measure': 'Mean Change of Plasma Cluster of Differentiation 4 (CD4+) T-Cell Count From Baseline Day 1 to Week 48', 'timeFrame': 'Baseline at Day 1 and Week 48', 'description': 'Plasma CD4+ T-Cell Count was measured in cells/mm\\^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean change of plasma CD4+ T-Cell count from baseline to Week 48 is presented.'}, {'measure': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Week 48 to Week 96', 'timeFrame': 'Baseline at Week 48 and Week 96', 'description': 'Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48.'}, {'measure': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 48 to Week 144', 'timeFrame': 'Baseline at Week 48 and Week 144', 'description': 'Mean change from baseline at Week 48 in CD4+ T-cell count at Week 144. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48.'}, {'measure': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 96', 'timeFrame': 'Baseline at Day 1 and Week 96', 'description': 'Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1.'}, {'measure': 'Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 144', 'timeFrame': 'Baseline at Day 1 and Week 144', 'description': 'Mean change from baseline at Day 1 in CD4+ T-cell count at Week 144. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1.'}, {'measure': 'Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48', 'timeFrame': 'Up to Week 48', 'description': 'Participants with clinically significant confirmed viremia \\[2 consecutive occurences 4 weeks (+-1 week) apart of HIV-1 RNA \\>=200 copies/mL at any time during the study\\] or who discontinue study intervention for another reason with HIV-1 RNA \\>=200 copies/mL at the time of discontinuation met the criteria for post-baseline resistance testing. Participants with HIV-1 RNA \\>=400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Plasma samples were collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and virus susceptibility to study intervention. The percentage of participants in the resistance analysis subset with treatment-emergent resistance-associated substitutions to the study intervention is presented.'}, {'measure': 'Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Low density lipoprotein cholesterol (LDL-C) at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented.'}, {'measure': 'Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Non-HDL-C at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented.'}, {'measure': 'Participants With One or More AEs at Week 96', 'timeFrame': 'Up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 96 is reported.'}, {'measure': 'Participants With One or More AEs at Week 144', 'timeFrame': 'Up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 144 is reported.'}, {'measure': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 96', 'timeFrame': 'Up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 96 are reported.'}, {'measure': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 144', 'timeFrame': 'Up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 144 are reported.'}, {'measure': 'Percentage of Participants With One or More AEs From Week 48 up to Week 96', 'timeFrame': 'Week 48 up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 96 is reported.'}, {'measure': 'Percentage of Participants With One or More AEs From Week 48 up to Week 144', 'timeFrame': 'Week 48 up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 144 is presented.'}, {'measure': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 96', 'timeFrame': 'Week 48 up to Week 96', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 96 are reported.'}, {'measure': 'Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 144', 'timeFrame': 'Week 48 up to Week 144', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 144 are reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26163&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \\<50 copies/mL at screening\n* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 RNA \\<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen\n* Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator\n\nExclusion Criteria:\n\n* Has HIV-2 infection\n* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator\n* Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening\n* Has active hepatitis B virus (HBV) infection\n* Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis\n* Has a ≤5 years prior history of malignancy\n* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers\n* Has taken long-acting HIV therapy at any time\n* Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period\n* Has a documented or known virologic resistance to Doravine (DOR)'}, 'identificationModule': {'nctId': 'NCT05631093', 'briefTitle': 'A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy', 'orgStudyIdInfo': {'id': '8591A-051'}, 'secondaryIdInfos': [{'id': 'MK-8591A-051', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2031220698', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': 'U1111-1283-3894', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2022-502127-22-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': '2022-502127-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOR/ISL', 'description': 'Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) receive doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).', 'interventionNames': ['Drug: DOR/ISL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ART + DOR/ISL', 'description': 'Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).', 'interventionNames': ['Drug: ART']}], 'interventions': [{'name': 'ART', 'type': 'DRUG', 'description': 'Standard of care ART, per approved product list, taken orally', 'armGroupLabels': ['ART + DOR/ISL']}, {'name': 'DOR/ISL', 'type': 'DRUG', 'otherNames': ['MK-8591A'], 'description': 'Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.', 'armGroupLabels': ['DOR/ISL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Infectious Disease ( Site 3014)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research ( Site 3032)', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center ( Site 3006)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34982', 'city': 'Ft. 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