A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF), Placebo matched to MK-8527, Placebo matched to FTC/TDF.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis. Basic parameters: 16 years — 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya, South Africa, Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug MK-8527
Oral tablet - Drug Emtricitabine/tenofovir disoproxil (FTC/TDF)
Oral tablet - Drug Placebo matched to MK-8527
Placebo oral tablet matched to MK-8527 - Drug Placebo matched to FTC/TDF
Placebo oral tablet matched to FTC/TDF
Primary outcome measures
- Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection [Time frame: Up to ~2 years]
- Number of Participants who Experience At Least One Adverse Event (AE) [Time frame: Up to ~2 years]
- Number of Participants who Discontinue Study Intervention Due to an AE [Time frame: Up to ~2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
South Africa · 21 centers
- Synergy Biomed Research Institute ( Site 0040) — East London
- Foundation For Professional Development ( Site 0031) — Ndevana
- Josha Research ( Site 0045) — Bloemfontein
- Wits RHI Ward 21 Clinical Research site ( Site 0022) — Johannesburg
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048) — Johannesburg
- Perinatal HIV Research Unit (PHRU) ( Site 0033) — Johnnesburg
- Setshaba Research Centre ( Site 0032) — Pretoria
- SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026) — Chatsworth
- … and 13 more centers
Uganda · 5 centers
- MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064) — Entebbe
- Infectious Diseases Institute Kalangala ( Site 0063) — Kalangala District
- MU-JHU Research Collaboration - Mityana ( Site 0061) — Mityana, District
- UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067) — Entebbe
- MU-JHU Research Collaboration - Kampala ( Site 0062) — Kampala
Kenya · 4 centers
- UW - KNH; Rachuonyo County Hospital ( Site 0006) — Homabay County
- Partners in Health and Research Development (PHRD) ( Site 0002) — Thika
- KEMRI-CMR-RCTP ( Site 0003) — Nairobi
- Kargeno Research & Policy Hub ( Site 0007) — Kisumu
Identifiers
NCT: NCT07071623 · 8527-010 · MK-8527-010