CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 4,580 target
Drug / intervention
MK-8527 +3 moredrug
Likely dose
11 mgfrom record
Key inclusion· 4
  • ✓HIV-uninfected confirmed by negative HIV-1/HIV-2 test
  • ✓2 or more vaginal intercourse encounters with cisgender male within last 3 months
  • ✓Assigned female sex at birth and cisgender
  • ✓Weight ≥35 kg
Key exclusion· 6
  • ✕Hypersensitivity or contraindication to study intervention components
  • ✕Evidence of acute or chronic hepatitis B infection
  • ✕Malignancy within 5 years except treated basal/squamous cell skin cancer or in situ cervical cancer
  • ✕Prior use of cabotegravir, lenacapavir, or other long-acting HIV prevention product

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07071623
NCT07071623Phase 3RecruitingHigh Momentum
CompareCT.gov

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 in Women

Merck Sharp & Dohme LLC·interventional·Posted Jul 17, 2025·Updated Jun 29, 2026

In Brief

A Phase 3 clinical trial evaluating MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF), and 2 other interventions for Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis. Currently recruiting, targeting 4,580 participants across 30 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed Summary

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
CountriesKenya, South Africa, Uganda
Collaborators--

Timeline

Phase 3Recruiting
20262027
First PostedJul 17, 2025
Enrollment StartNov 10, 2025
Primary CompletionOct 18, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12 months agoPrimary completion in 1.3 years

Arms & Interventions

MK-8527 + Placebo to FTC/TDFexperimental

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: MK-8527Drug: Placebo matched to FTC/TDF
FTC/TDF + Placebo to MK-8527active_comparator

Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: Emtricitabine/tenofovir disoproxil (FTC/TDF)Drug: Placebo matched to MK-8527

Interventions

MK-8527drug

Oral tablet

Emtricitabine/tenofovir disoproxil (FTC/TDF)drug

Oral tablet

Placebo matched to MK-8527drug

Placebo oral tablet matched to MK-8527

Placebo matched to FTC/TDFdrug

Placebo oral tablet matched to FTC/TDF