Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-24 @ 6:04 AM
Study NCT ID:
NCT02217904
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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 Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 21 days following administration of investigational drug', 'description': 'All participants who received at least one dose of investigational drug', 'eventGroups': [{'id': 'EG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral mucosa erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'groupId': 'OG000', 'lowerLimit': '-1.92', 'upperLimit': '-1.42'}, {'value': '-1.35', 'groupId': 'OG001', 'lowerLimit': '-1.60', 'upperLimit': '-1.10'}, {'value': '-1.60', 'groupId': 'OG002', 'lowerLimit': '-1.85', 'upperLimit': '-1.34'}, {'value': '-1.30', 'groupId': 'OG003', 'lowerLimit': '-1.55', 'upperLimit': '-1.05'}, {'value': '-1.20', 'groupId': 'OG004', 'lowerLimit': '-1.46', 'upperLimit': '-0.95'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Posterior mean difference', 'paramValue': '-1.64', 'estimateComment': 'Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \\>99%.', 'groupDescription': 'Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Posterior mean difference', 'paramValue': '-1.32', 'estimateComment': 'Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \\>99%.', 'groupDescription': 'Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Posterior mean difference', 'paramValue': '-1.57', 'estimateComment': 'Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \\>99%.', 'groupDescription': 'Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Posterior mean difference', 'paramValue': '-1.28', 'estimateComment': 'Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \\>99%.', 'groupDescription': 'Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Posterior mean difference', 'paramValue': '-1.18', 'estimateComment': 'Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \\>99%.', 'groupDescription': 'Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 168 hours (7 days) post-dose', 'description': 'Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With One or More Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days post-dose', 'description': 'An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of investigational drug'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '38.1', 'groupId': 'OG001'}, {'value': '926', 'spread': '47.7', 'groupId': 'OG002'}, {'value': '35.9', 'spread': '27.6', 'groupId': 'OG003'}, {'value': '23.1', 'spread': '83.0', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.', 'unitOfMeasure': 'hr*pmol/10^6 cells', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had AUC0-168hr of triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '0.495', 'spread': '62.9', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '60.3', 'groupId': 'OG002'}, {'value': '0.408', 'spread': '49.3', 'groupId': 'OG003'}, {'value': '0.263', 'spread': '54.5', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.', 'unitOfMeasure': 'pmol/10^6 cells', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Cmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.983', 'spread': '26', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '39.2', 'groupId': 'OG001'}, {'value': '4.83', 'spread': '85.9', 'groupId': 'OG002'}, {'value': '0.164', 'spread': '31.4', 'groupId': 'OG003'}, {'value': '0.116', 'spread': '85.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '168 hours after islatravir administration', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.', 'unitOfMeasure': 'pmol/10^6 cells', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had C168hr of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '240'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '144'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '96'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '24'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '4', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Tmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'spread': '42.2', 'groupId': 'OG000'}, {'value': '120', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '78.5', 'spread': '31.4', 'groupId': 'OG002'}, {'value': '118', 'spread': '16.1', 'groupId': 'OG003'}, {'value': '95.3', 'spread': '38.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '1020', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '143', 'spread': '39.6', 'groupId': 'OG001'}, {'value': '3020', 'spread': '24.6', 'groupId': 'OG002'}, {'value': '88.3', 'spread': '33.8', 'groupId': 'OG003'}, {'value': '38.3', 'spread': '25.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.', 'description': 'Blood was collected for the determination of AUC0-168hr of islatravir in plasma.', 'unitOfMeasure': 'hr*nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma AUC-168hr of islatravir data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Islatravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '235', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '51.2', 'groupId': 'OG001'}, {'value': '678', 'spread': '29.6', 'groupId': 'OG002'}, {'value': '38.8', 'spread': '31.3', 'groupId': 'OG003'}, {'value': '20.3', 'spread': '36.4', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of Cmax of islatravir in plasma.', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Cmax of islatravir data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of Islatravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.75', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG004', 'lowerLimit': '0.25', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of Tmax of islatravir in plasma.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Tmax of islatravir data available, and were evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'OG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'OG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'OG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'OG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '47.4', 'spread': '74.6', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '11.2', 'groupId': 'OG002'}, {'value': '10.4', 'spread': '144', 'groupId': 'OG003'}, {'value': '2.31', 'spread': '16.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir in plasma data available, and were evaluable for the outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'FG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'FG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'FG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'FG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}, {'id': 'FG005', 'title': 'Panel F: 0.25 mg Islatravir', 'description': 'Participants received a single does of 0.25 mg islatravir.'}, {'id': 'FG006', 'title': 'Panel G: 30 mg Islatravir Extended Observation', 'description': 'Participants received a single does of 30 mg islatravir.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Additional panels (F: 0.25 mg islatravir; and G: 30 mg islatravir Extended Observation) were initially planned but were not conducted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A: 10 mg Islatravir', 'description': 'Participants received a single dose of 10 mg islatravir.'}, {'id': 'BG001', 'title': 'Panel B: 2 mg Islatravir', 'description': 'Participants received a single dose of 2 mg islatravir.'}, {'id': 'BG002', 'title': 'Panel C: 30 mg Islatravir', 'description': 'Participants received a single dose of 30 mg islatravir.'}, {'id': 'BG003', 'title': 'Panel D: 1 mg Islatravir', 'description': 'Participants received a single dose of 1 mg islatravir.'}, {'id': 'BG004', 'title': 'Panel E: 0.5 mg Islatravir', 'description': 'Participants received a single dose of 0.5 mg islatravir.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '42.2', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '32.7', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '35.5', 'spread': '11.3', 'groupId': 'BG004'}, {'value': '35.5', 'spread': '10.6', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Plasma HIV-1 Ribonucleic Acid (RNA)', 'classes': [{'categories': [{'measurements': [{'value': '4.68', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '4.17', 'spread': '0.41', 'groupId': 'BG002'}, {'value': '4.66', 'spread': '0.2', 'groupId': 'BG003'}, {'value': '4.59', 'spread': '0.5', 'groupId': 'BG004'}, {'value': '4.56', 'spread': '0.40', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-21', 'size': 6021065, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-02T14:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2014-08-13', 'resultsFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2014-08-13', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-02', 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose', 'timeFrame': 'Baseline and 168 hours (7 days) post-dose', 'description': 'Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.'}, {'measure': 'Number of Participants With One or More Adverse Events', 'timeFrame': 'Up to 21 days post-dose', 'description': 'An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.'}, {'measure': 'Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.'}, {'measure': 'Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)', 'timeFrame': '168 hours after islatravir administration', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.'}, {'measure': 'Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.'}, {'measure': 'Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells', 'timeFrame': '4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.', 'description': 'Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.', 'description': 'Blood was collected for the determination of AUC0-168hr of islatravir in plasma.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Islatravir', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of Cmax of islatravir in plasma.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Islatravir', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of Tmax of islatravir in plasma.'}, {'measure': 'Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma', 'timeFrame': 'Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration', 'description': 'Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV-1']}, 'referencesModule': {'references': [{'pmid': '31911147', 'type': 'DERIVED', 'citation': 'Schurmann D, Rudd DJ, Zhang S, De Lepeleire I, Robberechts M, Friedman E, Keicher C, Huser A, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Matthews RP. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Lancet HIV. 2020 Mar;7(3):e164-e172. doi: 10.1016/S2352-3018(19)30372-8. Epub 2020 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female\n* Female with reproductive potential agrees to use (or have male partner use) two acceptable methods of birth control\n* Male agrees to use acceptable method of contraception during study and for 90 days after last dose of trial drug\n* Has stable baseline health, other than HIV infection\n* Has no significantly abnormal electrocardiogram\n* Is HIV-1 positive\n* Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the treatment phase of this study. For inclusion in Panel Islatravir Extended Observation, participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30 days prior to the treatment phase.\n* Is ART naive\n* Has not received any investigational agent or marketed ART within 30 days of trial drug administration\n* Is diagnosed with HIV-1 infection \\>= 3 months prior to screening\n* Is willing to receive no other ART during treatment phase of study\n* Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs)\n\nExclusion Criteria:\n\n* Is mentally or legally institutionalized/incapacitated, or has significant emotional problems, or has a history of clinically significant psychiatric disorder of the last 5 years\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, major neurological abnormalities or diseases\n* Has a history of cancer (malignancy)\n* Has a history of significant multiple and/or severe allergies, or had an anaphylactic reaction to drugs or food\n* Is positive for hepatitis B surface antigen\n* Has a history of chronic Hepatitis C\n* Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit\n* Has participated in another investigational trial within 4 weeks prior to dosing visit\n* Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing of trial drug, up to the post-trial visit\n* Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products\n* Uses illicit drugs or has a history of drug abuse within the prior 2 years'}, 'identificationModule': {'nctId': 'NCT02217904', 'briefTitle': 'A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients', 'orgStudyIdInfo': {'id': '8591-003'}, 'secondaryIdInfos': [{'id': '2014-002192-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-8591-003', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Islatravir 1 mg', 'description': 'Single oral dose of islatravir 1 mg', 'interventionNames': ['Drug: 1 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 2 mg', 'description': 'Single oral dose of islatravir 2 mg', 'interventionNames': ['Drug: 2 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 10 mg', 'description': 'Single oral dose of islatravir 10 mg', 'interventionNames': ['Drug: 10 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 30 mg', 'description': 'Single oral dose of islatravir 30 mg', 'interventionNames': ['Drug: 30 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 0.5 mg', 'description': 'Single oral dose of islatravir 0.5 mg', 'interventionNames': ['Drug: 0.5 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 0.25 mg', 'description': 'Single oral dose of islatravir 0.25 mg', 'interventionNames': ['Drug: 0.25 mg islatravir']}, {'type': 'EXPERIMENTAL', 'label': 'Islatravir 30 mg Extended Observation', 'description': 'Single oral dose of 30 mg islatravir administered following \\>8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART.', 'interventionNames': ['Drug: 30 mg islatravir']}], 'interventions': [{'name': '1 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 1 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 1 mg']}, {'name': '2 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 2 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 2 mg']}, {'name': '10 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 10 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 10 mg']}, {'name': '30 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 30 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 30 mg', 'Islatravir 30 mg Extended Observation']}, {'name': '0.5 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 0.5 mg']}, {'name': '0.25 mg islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast', 'armGroupLabels': ['Islatravir 0.25 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}