Status:

RECRUITING

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Human Immunodeficiency Virus (HIV)

HIV Pre-Exposure Prophylaxis

Eligibility:

FEMALE

16-30 years

Phase:

PHASE3

Brief 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 HI...

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results
  • Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)
  • Was assigned female sex at birth and is cisgender.
  • Weighs ≥35 kg

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • 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 cervical cancer
  • Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
  • 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

Key Trial Info

Start Date :

November 10 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 18 2027

Estimated Enrollment :

4580 Patients enrolled

Trial Details

Trial ID

NCT07071623

Start Date

November 10 2025

End Date

October 18 2027

Last Update

March 30 2026

Active Locations (29)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (29 locations)

1

UW - KNH; Rachuonyo County Hospital ( Site 0006)

Homabay County, Homa Bay County, Kenya, 40222

2

Partners in Health and Research Development (PHRD) ( Site 0002)

Thika, Kiambu County, Kenya, 00202

3

KEMRI-CMR-RCTP ( Site 0003)

Nairobi, Kisumu County, Kenya, 00200

4

Kargeno Research & Policy Hub ( Site 0007)

Kisumu, Kenya, 40123

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) | DecenTrialz