NCT06045507CompletedPhase 2
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 352 (actual)
- First submitted
- 13 Sept 2023
- Start date
- 8 Nov 2023
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT06045507
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 352
- From 8 Nov 2023 to the primary completion date, 12 Dec 2024
- 18 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of MK-8527 or islatravir (MK-8591)
Other illness
- 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 \[RNA\])
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus ( Site 0003) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center ( Site 0002) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center ( Site 0001) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Albuquerque Clinical Trials, Inc. ( Site 0044) Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Fenway Health ( Site 0043) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Prism Health North Texas, Oak Cliff Health Center ( Site 0045) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clinical Research, Hallandale Beach ( Site 0052) Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Community Medical Care Center ( Site 0056) Coordinator of this site? Confirm its status | Immokalee | United States | Unknown status |
| Velocity Clinical Research, North Hollywood ( Site 0054) Coordinator of this site? Confirm its status | North Hollywood | United States | Unknown status |
| University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Velocity Clinical Research Rockville ( Site 0048) Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Bridge HIV- San Francisco Department of Public Health ( Site 0042) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Josha Research ( Site 0023) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Desmond Tutu Health Foundation ( Site 0021) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Helen Joseph Hospital ( Site 0024) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Qhakaza Mbokodo Research Clinic ( Site 0026) Coordinator of this site? Confirm its status | Ladysmith | South Africa | Unknown status |
Related publications
- Alimatravir Oral Once Monthly in Adults With Low Likelihood of HIV Exposure: A Randomized, Double-Blind, Placebo-Controlled Study.J Infect Dis · 2026 · PMID 42770214
This page is information, not medical advice. Discuss any trial with your doctor.