At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 242 enrolled
Drug / intervention
Islatravir +1 moredrug
Likely dose
Islatravir 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Islatravir and Placebo for HIV-1 Infection. Completed, enrolled 242 participants across 9 sites in 3 countries.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesIsrael, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartSep 2019
Primary CompletionMar 2022
Study CompletionNov 2022
TodayJul 2026
First PostedJul 1, 2019
Enrollment StartSep 19, 2019
Primary CompletionMar 18, 2022
Study CompletionNov 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.0 years ago
Interventions
Islatravirdrug
Islatravir 30 mg capsules taken by mouth.
Placebodrug
Placebo capsules taken by mouth.