Actively Recruiting
A Phase 3, Randomized, Double-Blind Study Evaluating MK-8527 Oral Once-Monthly as HIV-1 Pre-Exposure Prophylaxis in Women
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-01
4580
Participants Needed
30
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating new medicines to prevent HIV-1 infection, focusing on women who are at risk. The study aims to find out if taking MK-8527 once a month can prevent HIV-1 infection better than the usual daily HIV prevention pill (known as PrEP). The research also looks at the safety of MK-8527 and how well people tolerate the medication. Participants will be randomly assigned to one of two groups for about two years. One group will take 11 mg of MK-8527 once a month along with a placebo pill daily, while the other group will take a daily dose of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) with a monthly placebo. After this period, all participants will take an open-label daily dose of FTC/TDF for 28 days. During the study, participants will be monitored for HIV-1 infection, side effects, and whether they stop treatment due to side effects. Safety and effectiveness will be assessed over the two years of treatment. The study includes regular check-ins to evaluate health and collect information about adverse events associated with the treatments.
CONDITIONS
Brief Title
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV-uninfected by negative HIV-1/HIV-2 tests
- Sexually active with at least 2 vaginal intercourse encounters with cisgender male partners in the last 3 months
- Assigned female sex at birth and identifies as cisgender female
- Weighs at least 35 kg
You will not qualify if you...
- Has hypersensitivity or contraindication to any study intervention component
- Has acute or chronic hepatitis B infection
- History of malignancy within 5 years except treated basal or squamous cell skin cancer or in situ cervical cancer
- Has taken cabotegravir, lenacapavir, or other long-acting HIV prevention products
- Currently receiving or expected to need prohibited therapies from 30 days before Day 1 through study
- Received any HIV vaccine or monoclonal antibodies to HIV within 12 months before Day 1
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 2 years
Participants take oral tablets once monthly or daily to prevent HIV-1 infection for up to approximately 2 years.
Monthly and daily medication intake visits
Duration - 28 days
Participants receive open-label FTC/TDF daily for an additional 28 days after treatment ends.
1 follow-up visit
Trial Site Locations
Total: 30 locations
1
UW - KNH; Rachuonyo County Hospital ( Site 0006)
Homabay County, Homa Bay County, Kenya, 40222
Actively Recruiting
2
Partners in Health and Research Development (PHRD) ( Site 0002)
Thika, Kiambu County, Kenya, 00202
Actively Recruiting
3
KEMRI-CMR-RCTP ( Site 0003)
Nairobi, Kisumu County, Kenya, 00200
Actively Recruiting
4
Kargeno Research & Policy Hub ( Site 0007)
Kisumu, Kenya, 40123
Actively Recruiting
5
Synergy Biomed Research Institute ( Site 0040)
East London, Eastern Cape, South Africa, 5241
Actively Recruiting
6
Foundation For Professional Development ( Site 0031)
Ndevana, Eastern Cape, South Africa, 5660
Actively Recruiting
7
Josha Research ( Site 0045)
Bloemfontein, Free State, South Africa, 9301
Actively Recruiting
8
Wits RHI Ward 21 Clinical Research site ( Site 0022)
Johannesburg, Gauteng, South Africa, 2001
Actively Recruiting
9
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)
Johannesburg, Gauteng, South Africa, 2092
Actively Recruiting
10
Perinatal HIV Research Unit (PHRU) ( Site 0033)
Johnnesburg, Gauteng, South Africa, 1864
Actively Recruiting
11
Setshaba Research Centre ( Site 0032)
Pretoria, Gauteng, South Africa, 0152
Actively Recruiting
12
SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)
Chatsworth, KwaZulu-Natal, South Africa, 4092
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13
SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)
Durban, KwaZulu-Natal, South Africa, 3660
Actively Recruiting
14
CAPRISA eThekwini Clinical Research Site ( Site 0030)
Durban, KwaZulu-Natal, South Africa, 4001
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15
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
16
Umlazi Clinical Research Site ( Site 0047)
Durban, KwaZulu-Natal, South Africa, 4089
Actively Recruiting
17
SYNAPSE Research Clinic ( Site 0043)
Edendale, KwaZulu-Natal, South Africa, 3216
Actively Recruiting
18
Qhakaza Mbokodo Research Clinic ( Site 0028)
Ladysmith, KwaZulu-Natal, South Africa, 3370
Actively Recruiting
19
SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)
Phoenix, KwaZulu-Natal, South Africa, 4068
Actively Recruiting
20
CAPRISA Vulindlela Clinical Research Site ( Site 0029)
Pietermaritzburg, KwaZulu-Natal, South Africa, 3231
Actively Recruiting
21
Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)
Somkhele - Mtubatuba, KwaZulu-Natal, South Africa, 3935
Actively Recruiting
22
SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)
Verulam, KwaZulu-Natal, South Africa, 4340
Actively Recruiting
23
Desmond Tutu Health Foundation. Philippi Village ( Site 0024)
Cape Town, Western Cape, South Africa, 7781
Actively Recruiting
24
DTHF Masiphumelele Clinical Research Site ( Site 0023)
Cape Town, Western Cape, South Africa, 7795
Actively Recruiting
25
Vuka Research Clinic ( Site 0025)
Khayelitsha, Western Cape, South Africa, 7784
Actively Recruiting
26
MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064)
Entebbe, Central Region, Uganda, 256
Actively Recruiting
27
Infectious Diseases Institute Kalangala ( Site 0063)
Kalangala District, Kalangala, Uganda, 30060/+256
Actively Recruiting
28
MU-JHU Research Collaboration - Mityana ( Site 0061)
Mityana, District, Mityana, Uganda, 30026/+256
Actively Recruiting
29
UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)
Entebbe, Wakiso, Uganda, 30006
Actively Recruiting
30
MU-JHU Research Collaboration - Kampala ( Site 0062)
Kampala, Uganda, 10216/+256
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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