NCT07044297Active, not recruitingPhase 3
A clinical study of MK-8527 to prevent HIV-1 (MK-8527-011)
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Jul 2026
Brief summary (registry, in English)
1. To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections. 2. To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Jun 2025
- Start date
- 19 Nov 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- EU CT number
- 2025-520610-58-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
- Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
Other illness
- Has hypersensitivity or other contraindication to any component of the study interventions
- Has evidence of acute or chronic hepatitis B infection
- Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
- Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
Other
- Is expecting to donate eggs at any time during the study
Who the study is looking for
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
- Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
- Is ≥16 years of age
- Weighs ≥35 kg
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.