Actively Recruiting
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-04
4580
Participants Needed
30
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 with negative HIV-1/HIV-2 test results
- Sexually active with at least 2 vaginal intercourse encounters with cisgender male(s) in the last 3 months
- Assigned female sex at birth and is cisgender
- Weighs at least 35 kilograms
You will not qualify if you...
- Allergic or sensitive to any component of the study drugs
- Has acute or chronic hepatitis B infection
- Has had cancer within the last 5 years except for treated basal or squamous cell skin cancer or in situ cervical cancer
- Has used cabotegravir, lenacapavir, or any other long-acting HIV prevention product before
- Is using or needs prohibited therapies from 30 days before the study start through the study
- Has received an HIV vaccine or monoclonal antibodies to HIV within 12 months before the study start
AI-Screening
AI-Powered Screening
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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
Actively Recruiting
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
Actively Recruiting
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
T
Toll Free Number
CONTACT
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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