CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 4,390 target
Drug / intervention
MK-8527 +3 moredrug
Likely dose
11 mgfrom record
Key inclusion· 4
  • ✓Confirmed HIV-uninfected with negative HIV-1/HIV-2 test results
  • ✓Cisgender man, transgender woman, transgender man, or gender nonbinary person
  • ✓Condomless receptive anal sex in past 12 months outside mutually monogamous relationships plus additional risk criteria
  • ✓Body weight ≥35 kg
Key exclusion· 7
  • ✕Hypersensitivity or contraindication to study intervention components
  • ✕Evidence of acute or chronic hepatitis B infection
  • ✕History of malignancy within 5 years except basal/squamous cell skin cancer or in situ anal/cervical cancers
  • ✕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/NCT07044297
NCT07044297Phase 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

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

In Brief

A Phase 3 clinical trial evaluating MK-8527, FTC/TDF, and 2 other interventions for Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis. Currently recruiting, targeting 4,390 participants across 81 sites in 16 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 as well as or 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
CountriesArgentina, Brazil, Chile, Colombia, Dominican Republic, France, Guatemala, Kenya, Malaysia, Peru, Philippines, South Africa, Switzerland, Thailand, United States, Vietnam
Collaborators--

Timeline

Phase 3Recruiting
20262027
First PostedJun 29, 2025
Enrollment StartJul 31, 2025
Primary CompletionJul 22, 2027
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 1.0 years agoPrimary completion in 1.1 years

Arms & Interventions

MK-8527experimental

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to 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: FTC/TDFDrug: Placebo to FTC/TDF
FTC/TDFactive_comparator

Participants will receive 200 mg FTC/245 mg TDF QD and placebo 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: FTC/TDFDrug: Placebo to MK-8527

Interventions

MK-8527drug

Oral tablet

FTC/TDFdrug

Oral tablet

Placebo to MK-8527drug

Placebo tablet matched to MK-8527

Placebo to FTC/TDFdrug

Placebo tablet matched to FTC/TDF