Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 2:33 PM
Study NCT ID:
NCT04003103
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558823', 'term': 'islatravir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 36 weeks', 'description': 'All treated participants are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 24, 'seriousNumAtRisk': 97, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 23, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 16, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 27, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Adverse Event (AE) Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'An AE is 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing From Study Therapy Due to AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 20 weeks', 'description': 'An AE is 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 20 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Drug-related AE Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Serious Adverse Event (SAE) Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': "An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study therapy, whether or not considered related to the study intervention. Toxicity grading was according to the National Institutes of Health Division of AIDS (NIH DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events version 2.1 (Grade 3 is 'severe'; Grade 4 is 'potentially life-threatening'; and Grade 5 'results in death').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Drug-related SAE Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'An drug-related SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered related to study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'A drug-related Grade 3 to Grade 5 AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention; has a toxicity Grade 3 (severe), 4 (potentially life-threatening), or 5 (results in death); and is considered related to study therapy. Toxicity grading was according to the NIH DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v. 2.1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an AE Resulting in Death Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 weeks', 'description': 'An AE is 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.88', 'spread': '56.8', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '50.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '140.3', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '136.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 140: predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The AUC0-672 of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.', 'unitOfMeasure': 'hr*umol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'ISL-treated participants with data available who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of ISL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.387', 'spread': '279.9', 'groupId': 'OG000'}, {'value': '0.954', 'spread': '186.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.376', 'spread': '597.7', 'groupId': 'OG000'}, {'value': '0.792', 'spread': '349.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The Cmax of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'ISL-treated participants with data available who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration (Ctrough) of ISL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000556', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '0.00101', 'spread': '37.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000809', 'spread': '37.0', 'groupId': 'OG000'}, {'value': '0.000124', 'spread': '42.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 20: predose and 30-min postdose. Day 2: 24 hours post Day 1 dose. Weeks 1, 2, 3, 21, 22, 23 and 24: any time during the study visit. Weeks 4, 8, 12 and 16: predose.', 'description': 'The plasma Ctrough of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'ISL-treated participants with data available who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Apparent Plasma Terminal Half-life (t1/2) of ISL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Insufficient data available on Day 1.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Insufficient data available on Day 1.', 'groupId': 'OG001'}]}]}, {'title': 'Day 140', 'categories': [{'measurements': [{'value': '175', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '177', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The plasma t1/2 of ISL after dosing on Day 140 is reported. Only ISL-treated participants are included in the PK analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'ISL-treated participants with data available who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 AE Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 Drug-related AE Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 SAE Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': "An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study therapy, whether or not considered related to the study intervention. Toxicity grading was according to the National Institutes of Health Division of AIDS (NIH DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events version 2.1 (Grade 3 is 'severe'; Grade 4 is 'potentially life-threatening'; and Grade 5 'results in death').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 Drug-related SAE Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'An drug-related SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered related to study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'A drug-related Grade 3 to Grade 5 AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention; has a toxicity Grade 3 (severe), 4 (potentially life-threatening), or 5 (results in death); and is considered related to study therapy. Toxicity grading was according to the NIH DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v. 2.1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an AE Resulting in Death Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study therapy are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'FG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Status not recorded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy HIV-uninfected male and female participants were enrolled at 9 study centers in 3 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Islatravir 60 mg', 'description': 'Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'BG001', 'title': 'Islatravir 120 mg', 'description': 'Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '32.9', 'spread': '9.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-08', 'size': 916634, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-21T16:42', 'hasProtocol': True}, {'date': '2021-12-08', 'size': 1646377, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-21T16:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2019-06-27', 'resultsFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-21', 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With ≥1 Adverse Event (AE) Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'An AE is 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.'}, {'measure': 'Number of Participants Discontinuing From Study Therapy Due to AE', 'timeFrame': 'Up to 20 weeks', 'description': 'An AE is 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.'}, {'measure': 'Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE', 'timeFrame': 'Up to 20 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study therapy.'}, {'measure': 'Number of Participants With ≥1 Drug-related AE Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.'}, {'measure': 'Number of Participants With ≥1 Serious Adverse Event (SAE) Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.'}, {'measure': 'Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36', 'timeFrame': 'Up to 36 weeks', 'description': "An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study therapy, whether or not considered related to the study intervention. Toxicity grading was according to the National Institutes of Health Division of AIDS (NIH DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events version 2.1 (Grade 3 is 'severe'; Grade 4 is 'potentially life-threatening'; and Grade 5 'results in death')."}, {'measure': 'Number of Participants With ≥1 Drug-related SAE Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'An drug-related SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered related to study therapy.'}, {'measure': 'Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'A drug-related Grade 3 to Grade 5 AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention; has a toxicity Grade 3 (severe), 4 (potentially life-threatening), or 5 (results in death); and is considered related to study therapy. Toxicity grading was according to the NIH DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v. 2.1).'}, {'measure': 'Number of Participants With an AE Resulting in Death Through Week 36', 'timeFrame': 'Up to 36 weeks', 'description': 'An AE is 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.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL', 'timeFrame': 'Day 1 and Day 140: predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The AUC0-672 of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of ISL', 'timeFrame': 'Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The Cmax of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.'}, {'measure': 'Trough Plasma Concentration (Ctrough) of ISL', 'timeFrame': 'Day 1 and Week 20: predose and 30-min postdose. Day 2: 24 hours post Day 1 dose. Weeks 1, 2, 3, 21, 22, 23 and 24: any time during the study visit. Weeks 4, 8, 12 and 16: predose.', 'description': 'The plasma Ctrough of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.'}, {'measure': 'Apparent Plasma Terminal Half-life (t1/2) of ISL', 'timeFrame': 'Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.', 'description': 'The plasma t1/2 of ISL after dosing on Day 140 is reported. Only ISL-treated participants are included in the PK analysis.'}, {'measure': 'Number of Participants With ≥1 AE Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is 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.'}, {'measure': 'Number of Participants With ≥1 Drug-related AE Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.'}, {'measure': 'Number of Participants With ≥1 SAE Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.'}, {'measure': 'Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 24', 'timeFrame': 'Up to 24 weeks', 'description': "An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study therapy, whether or not considered related to the study intervention. Toxicity grading was according to the National Institutes of Health Division of AIDS (NIH DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events version 2.1 (Grade 3 is 'severe'; Grade 4 is 'potentially life-threatening'; and Grade 5 'results in death')."}, {'measure': 'Number of Participants With ≥1 Drug-related SAE Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'An drug-related SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered related to study therapy.'}, {'measure': 'Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'A drug-related Grade 3 to Grade 5 AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention; has a toxicity Grade 3 (severe), 4 (potentially life-threatening), or 5 (results in death); and is considered related to study therapy. Toxicity grading was according to the NIH DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v. 2.1).'}, {'measure': 'Number of Participants With an AE Resulting in Death Through Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '40327547', 'type': 'RESULT', 'citation': 'Hillier SL, Bekker LG, Riddler SA, Hendrix CW, Badal-Faesen S, Macdonald P, Nair G, Lombaard J, Caraco Y, Peer A, Patel M, Vargo R, Homony B, Nedrow K, Evans B, Wickremasingha P, Zhou YP, Teal V, Hwang P, McMullan C, Kaufman KD, Robertson MN, Plank RM. Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1. J Infect Dis. 2025 Nov 14;232(5):1050-1060. doi: 10.1093/infdis/jiaf222.'}, {'pmid': '40260892', 'type': 'DERIVED', 'citation': 'Pham M, Wickremasingha P, Vargo R, Patel M, Nedrow K, Homony B, Robertson MN, Plank RM. Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives. J Acquir Immune Defic Syndr. 2025 Apr 22;99(4):374-8. doi: 10.1097/QAI.0000000000003678. Online ahead of print.'}, {'pmid': '33540481', 'type': 'DERIVED', 'citation': 'Devanathan AS, Cottrell ML. Pharmacology of HIV Cure: Site of Action. Clin Pharmacol Ther. 2021 Apr;109(4):841-855. doi: 10.1002/cpt.2187. Epub 2021 Mar 5.'}], 'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection', 'detailedDescription': 'This study is ongoing for collection of safety follow-up of infants born to mothers participating in the study. The present results are based on the Week 68 interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is in general good health with acceptable laboratory values at screening\n* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization\n* Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)\n* Use contraceptives consistent with local regulations\n* Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)\n* A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.\n\nExclusion Criteria:\n\n* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator\n* Has an active diagnosis of hepatitis due to any cause\n* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day\n\n 1 through the duration of the study.\n* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.\n* Has previously been randomized in a study and received islatravir (MK-8591).\n* Female is expecting to conceive or donate eggs at any time during the study\n* Has QTc interval (using Fridericia correction) \\>450 msec (for males) or \\>460 msec (for females) or deemed clinically abnormal by the investigator.'}, 'identificationModule': {'nctId': 'NCT04003103', 'briefTitle': 'Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8591 Once-Monthly in Participants at Low- Risk for HIV-1 Infection', 'orgStudyIdInfo': {'id': '8591-016'}, 'secondaryIdInfos': [{'id': 'Merck Protocol Number', 'type': 'OTHER', 'domain': 'MK-8591-016'}, {'id': '2019-001704-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Islatravir 60 mg', 'description': '60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks', 'interventionNames': ['Drug: Islatravir', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 120 mg', 'description': '120 mg islatravir administered once monthly, orally in capsule form for 24 weeks', 'interventionNames': ['Drug: Islatravir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Islatravir 30 mg capsules taken by mouth.', 'armGroupLabels': ['Islatravir 120 mg', 'Islatravir 60 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules taken by mouth.', 'armGroupLabels': ['Islatravir 60 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America, LLC ( Site 0007)', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine - Drug Development Unit ( Site 0002)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion, Inc. ( Site 0006)', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Research Institute ( Site 0001)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '9112001', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein Karem Jerusalem ( Site 0016)', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center ( Site 0017)', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'JOSHA Research ( Site 0015)', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '2092', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Clinical HIV Research Unit CHRU ( Site 0014)', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7750', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Emavundleni Vaccine Centre ( Site 0011)', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}