# 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)

> **NCT04003103** · PHASE2 · COMPLETED · sponsor: **Merck Sharp & Dohme LLC** · enrollment: 242 (actual)

## Conditions studied

- HIV-1 Infection

## Interventions

- **DRUG:** Islatravir
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04003103
- **Lead sponsor:** Merck Sharp & Dohme LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-09-19
- **Primary completion:** 2022-03-18
- **Final completion:** 2022-11-24
- **Target enrollment:** 242 (ACTUAL)
- **Last updated:** 2025-07-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04003103

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04003103, "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)". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT04003103. Licensed CC0.

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