Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV, HIV Pre-exposure Prophylaxis

In brief

This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

Key facts

Study ID

NCT06045507

Run by

Merck Sharp & Dohme LLC

People needed

352

Starts

2023-11-08

Expected to finish

2025-02-12

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
• Has low-risk of HIV infection
• Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse

You may not qualify if…

• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
• Prior use of MK-8527 or islatravir (MK-8591)

Where it is running

• Velocity Clinical Research, North Hollywood ( Site 0054) — North Hollywood, California, United States
• Bridge HIV- San Francisco Department of Public Health ( Site 0042) — San Francisco, California, United States
• Velocity Clinical Research, Hallandale Beach ( Site 0052) — Hallandale, Florida, United States
• Community Medical Care Center ( Site 0056) — Immokalee, Florida, United States
• Velocity Clinical Research Rockville ( Site 0048) — Rockville, Maryland, United States
• Fenway Health ( Site 0043) — Boston, Massachusetts, United States
• Albuquerque Clinical Trials, Inc. ( Site 0044) — Albuquerque, New Mexico, United States
• University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041) — Pittsburgh, Pennsylvania, United States
• Prism Health North Texas, Oak Cliff Health Center ( Site 0045) — Dallas, Texas, United States
• Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057) — Seattle, Washington, United States
• Rambam Health Care Campus ( Site 0003) — Haifa, Israel
• Hadassah Medical Center ( Site 0002) — Jerusalem, Israel
• Sheba Medical Center ( Site 0001) — Ramat Gan, Israel
• Josha Research ( Site 0023) — Bloemfontein, Free State, South Africa
• Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027) — Johannesburg, Gauteng, South Africa
• Helen Joseph Hospital ( Site 0024) — Johannesburg, Gauteng, South Africa
• Qhakaza Mbokodo Research Clinic ( Site 0026) — Ladysmith, KwaZulu-Natal, South Africa
• Desmond Tutu Health Foundation ( Site 0021) — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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