A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
NCT07071623
Phase
Phase 3
Recruitment status
Recruiting
Participants
4,580
Lead sponsor
Merck Sharp & Dohme LLC
Start date
2025-11-10
Number of sites
- 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
- Short title
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-10-18
- First posted
- 2025-07-17
- Registry last updated
- 2026-08-28
- Primary completion date
- 2027-10-18
- Start date
- 2025-11-10
- Participants
- 4,580
- Participant count basis
- Estimated
- Planned participants
- 4,580
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07071623
- ClinicalTrials.gov ID
- NCT07071623
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Timeframe: Up to ~2 years
The number of participants with adjudicated HIV-1 infection will be presented.
Number of Participants who Experience At Least One Adverse Event (AE)
Timeframe: Up to ~2 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be presented.
Number of Participants who Discontinue Study Intervention Due to an AE
Timeframe: Up to ~2 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be presented.
Sources for outcomes
- Sex
- Female
- Age groups
- Children, Adults
- Minimum age
- 16 Years
- Maximum age
- 30 Years
- Healthy volunteers
- Yes
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
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
Sources for eligibility
- UW - KNH; Rachuonyo County Hospital ( Site 0006)Homabay County, KenyaRecruiting
- Partners in Health and Research Development (PHRD) ( Site 0002)Thika, KenyaRecruiting
- KEMRI-CMR-RCTP ( Site 0003)Nairobi, KenyaRecruiting
- Kargeno Research & Policy Hub ( Site 0007)Kisumu, KenyaRecruiting
- Synergy Biomed Research Institute ( Site 0040)East London, South AfricaRecruiting
- Foundation For Professional Development ( Site 0031)Ndevana, South AfricaActive, not recruiting
- Josha Research ( Site 0045)Bloemfontein, South AfricaActive, not recruiting
- Wits RHI Ward 21 Clinical Research site ( Site 0022)Johannesburg, South AfricaRecruiting
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)Johannesburg, South AfricaRecruiting
- Perinatal HIV Research Unit (PHRU) ( Site 0033)Johnnesburg, South AfricaRecruiting
- Setshaba Research Centre ( Site 0032)Pretoria, South AfricaRecruiting
- SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)Chatsworth, South AfricaActive, not recruiting
- SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)Durban, South AfricaRecruiting
- CAPRISA eThekwini Clinical Research Site ( Site 0030)Durban, South AfricaRecruiting
- Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)Durban, South AfricaRecruiting
- Umlazi Clinical Research Site ( Site 0047)Durban, South AfricaRecruiting
- SYNAPSE Research Clinic ( Site 0043)Edendale, South AfricaRecruiting
- Qhakaza Mbokodo Research Clinic ( Site 0028)Ladysmith, South AfricaRecruiting
- SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)Phoenix, South AfricaRecruiting
- CAPRISA Vulindlela Clinical Research Site ( Site 0029)Pietermaritzburg, South AfricaRecruiting
- Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)Somkhele - Mtubatuba, South AfricaRecruiting
- SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)Verulam, South AfricaRecruiting
- Desmond Tutu Health Foundation. Philippi Village ( Site 0024)Cape Town, South AfricaRecruiting
- DTHF Masiphumelele Clinical Research Site ( Site 0023)Cape Town, South AfricaActive, not recruiting
- Vuka Research Clinic ( Site 0025)Khayelitsha, South AfricaActive, not recruiting
And 5 more, listed on the interactive page.
Sources for sites
- Related resource (www.merckclinicaltrials.com)
Other registry identifiers
- MK-8527-010
Sources for references
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Acquired immunodeficiency
- Susceptibility to HIV infection Primary condition