Trials / Completed
CompletedNCT04003103
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)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Islatravir | Islatravir 30 mg capsules taken by mouth. |
| DRUG | Placebo | Placebo capsules taken by mouth. |
Timeline
- Start date
- 2019-09-19
- Primary completion
- 2022-03-18
- Completion
- 2022-11-24
- First posted
- 2019-07-01
- Last updated
- 2025-07-18
- Results posted
- 2023-03-21
Locations
9 sites across 3 countries: United States, Israel, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04003103. Inclusion in this directory is not an endorsement.