Actively Recruiting
A Phase 3, Randomized, Active-Controlled, Double-Blind Study to Evaluate the Safety and Effectiveness of MK-8527 Taken Once Monthly as HIV-1 Pre-Exposure Prophylaxis
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
4390
Participants Needed
81
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 (HIV-1). This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is as effective or better than a standard daily pre-exposure prophylaxis (PrEP) in preventing HIV-1 infection. The study also assesses the safety and tolerability of MK-8527. Participants are randomly assigned to one of two groups: one group takes 11 mg of MK-8527 once monthly plus a placebo daily pill matching FTC/TDF, and the other group takes 200 mg FTC/245 mg TDF daily plus a placebo monthly pill matching MK-8527. This treatment phase lasts up to approximately two years. Afterward, all participants receive open-label FTC/TDF daily for an additional 28 days. During the study, participants are closely monitored for HIV-1 infection, adverse events, and any discontinuation due to side effects over the two-year treatment period. The primary outcomes include the number of participants who acquire HIV-1 infection, experience any adverse events, or stop the study intervention because of adverse events. Follow-up and safety assessments continue through the entire treatment period to evaluate the medicine's performance and participant well-being.
CONDITIONS
Brief Title
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- Identify as cisgender man, transgender woman (assigned male at birth), transgender man (assigned female at birth), or gender nonbinary person
- Had condomless receptive anal sex in the 12 months before screening outside a mutually monogamous relationship
- Have at least one of the following: receptive anal sex with two or more partners in the 3 months before screening, recent rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months before screening, or stimulant drug use with sex in the 3 months before screening
- Weigh at least 35 kg
You will not qualify if you...
- Hypersensitivity or contraindication to any study intervention component
- Evidence of acute or chronic hepatitis B infection
- History of malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
- Prior use of cabotegravir, lenacapavir, or other long-acting HIV prevention products
- Receiving or expected to require prohibited therapies from 30 days before Day 1 through study duration
- Previous HIV vaccine or monoclonal antibody to HIV within 12 months before Day 1
- Expecting to donate eggs during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants take study medication once monthly or daily depending on their assigned group to prevent HIV-1 infection.
Monthly visits for up to 2 years
Duration - 28 days
Participants receive open-label FTC/TDF daily for an additional 28 days after the treatment period.
Approximately 1 follow-up visit at the end of treatment
Trial Site Locations
Total: 81 locations
1
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama, United States, 35222
Actively Recruiting
2
USA Health University Hospitals ( Site 0020)
Mobile, Alabama, United States, 36617
Actively Recruiting
3
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California, United States, 90035
Actively Recruiting
4
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California, United States, 94102
Actively Recruiting
5
Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia, United States, 20032
Actively Recruiting
6
University of Miami RAPID Research ( Site 0003)
Miami, Florida, United States, 33136
Actively Recruiting
7
Orlando Immunology Center ( Site 0021)
Orlando, Florida, United States, 32803
Actively Recruiting
8
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia, United States, 30030
Actively Recruiting
9
University of Illinois Chicago ( Site 0027)
Chicago, Illinois, United States, 60612
Actively Recruiting
10
University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana, United States, 70112
Actively Recruiting
11
Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi, United States, 39202
Actively Recruiting
12
Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey, United States, 07103
Actively Recruiting
13
Montefiore Medical Center ( Site 0017)
The Bronx, New York, United States, 10467
Actively Recruiting
14
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina, United States, 27514-7064
Actively Recruiting
15
Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina, United States, 27401
Actively Recruiting
16
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
17
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
18
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina, United States, 29203
Actively Recruiting
19
St. Jude Children's Research Hospital ( Site 0026)
Memphis, Tennessee, United States, 38105
Actively Recruiting
20
Meharry Medical College ( Site 0013)
Nashville, Tennessee, United States, 37208
Actively Recruiting
21
Central Texas Clinical Research ( Site 0014)
Austin, Texas, United States, 78705
Actively Recruiting
22
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas, United States, 77401
Actively Recruiting
23
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington, United States, 98104
Actively Recruiting
24
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA, Buenos Aires, Argentina, C1002ABN
Actively Recruiting
25
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
CABA, Buenos Aires, Argentina, C1425AGC
Actively Recruiting
26
Fundación Huésped ( Site 0350)
CABA, Buenos Aires, Argentina, C1427CEA
Actively Recruiting
27
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
28
Fundación IDEAA ( Site 0351)
Buenos Aires, Argentina, C1405CKC
Actively Recruiting
29
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus, Amazonas, Brazil, 69040-000
Actively Recruiting
30
Obras Sociais Irma Dulce ( Site 0406)
Salvador, Estado de Bahia, Brazil, 41680-430
Actively Recruiting
31
School of Medicine Federal University of Minas Gerais ( Site 0417)
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
32
Hospital Geral de Nova Iguacu ( Site 0411)
Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
Actively Recruiting
33
Ricardo Diaz Scientific Solutions ( Site 0402)
São Paulo, São Paulo, Brazil, 04030-030
Actively Recruiting
34
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
São Paulo, São Paulo, Brazil, 04121-000
Actively Recruiting
35
Hospital das Clinicas FMUSP ( Site 0401)
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
36
Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)
Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
37
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco, Araucania, Chile, 4781151
Actively Recruiting
38
Universidad San Sebastian - Providencia ( Site 0454)
Santiago, Region M. de Santiago, Chile, 7500000
Actively Recruiting
39
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
Santiago, Region M. de Santiago, Chile, 8380420
Actively Recruiting
40
IPS SURA San Diego ( Site 0500)
Medellín, Antioquia, Colombia, 50016
Actively Recruiting
41
Clinica de la Costa S.A.S. ( Site 0501)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
42
Hospital Universitario San Ignacio ( Site 0503)
Bogotá, Bogota D.C., Colombia, 110231
Active, Not Recruiting
43
Fundación Valle del Lili ( Site 0502)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
44
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo, Nacional, Dominican Republic, 10104
Actively Recruiting
45
Endocardio ( Site 1003)
Santo Domingo, Nacional, Dominican Republic, 10147
Actively Recruiting
46
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
Santo Domingo de Guzman, Santo Domingo Province, Dominican Republic, 10306
Actively Recruiting
47
Hopital Saint Louis ( Site 0100)
Paris, France, 75010
Active, Not Recruiting
48
Hôpital Tenon ( Site 0102)
Paris, France, 75970
Active, Not Recruiting
49
Hopital Bichat - Claude Bernard ( Site 0101)
Paris, Île-de-France Region, France, 75018
Active, Not Recruiting
50
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City, Guatemala, 01009
Actively Recruiting
51
MEDI-K ( Site 1053)
Guatemala City, Guatemala, 01009
Actively Recruiting
52
CELAN,S.A ( Site 1052)
Guatemala City, Guatemala, 01010
Actively Recruiting
53
Partners for Health and Development in Africa ( Site 0201)
Nairobi, Nairobi City, Kenya, 00506
Actively Recruiting
54
Kargeno Research & Policy Hub ( Site 0200)
Kisumu, Kenya, 40123
Actively Recruiting
55
Impact Research and Development Organisation (IRDO) ( Site 0202)
Kisumu, Kenya, 40141
Actively Recruiting
56
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur, Malaysia, 50603
Actively Recruiting
57
Asociación Civil Selva Amazónica ( Site 0556)
Iquitos, Loreto, Peru, 16001
Active, Not Recruiting
58
Via Libre ( Site 0551)
Lima, Peru, 15001
Active, Not Recruiting
59
Policlínico Socios en Salud ( Site 0557)
Lima, Peru, 15024
Active, Not Recruiting
60
Investigaciones Medicas en Salud ( Site 0552)
Lima, Peru, 15046
Actively Recruiting
61
Asociación Civil Impacta Salud y Educación ( Site 0553)
Lima, Peru, 15063
Active, Not Recruiting
62
Universidad Nacional Mayor De San Marcos ( Site 0555)
Lima, Peru, 15081
Actively Recruiting
63
LoveYourself Inc. ( Site 0705)
Mandaluyong, National Capital Region, Philippines, 1552
Actively Recruiting
64
Philippine General Hospital ( Site 0700)
Manila, National Capital Region, Philippines, 1000
Actively Recruiting
65
Asian Hospital and Medical Center ( Site 0704)
Muntinlupa, National Capital Region, Philippines, 1780
Actively Recruiting
66
Foundation For Professional Development ( Site 0257)
King Williams Town, Eastern Cape, South Africa, 5660
Actively Recruiting
67
Wits RHI Research Center ( Site 0251)
Johannesburg, Gauteng, South Africa, 2001
Actively Recruiting
68
Setshaba Research Centre ( Site 0252)
Pretoria, Gauteng, South Africa, 0152
Actively Recruiting
69
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto, Gauteng, South Africa, 1864
Actively Recruiting
70
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
71
Desmond Tutu Health Foundation ( Site 0250)
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
72
University Hospital Basel ( Site 1102)
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
73
Inselspital Bern ( Site 1103)
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
74
Checkpoint Zurich ( Site 1100)
Zurich, Switzerland, 8005
Actively Recruiting
75
Chulalongkorn Hospital ( Site 0807)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
76
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
77
Institute of HIV Research and Innovation ( Site 0810)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
78
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok, Bangkok, Thailand, 10700
Active, Not Recruiting
79
Research Institute for Health Sciences ( Site 0809)
Muang, Chiang Mai, Thailand, 50200
Actively Recruiting
80
Hanoi Medical University Hospital ( Site 0851)
Hanoi, Hanoi, Vietnam, 100000
Active, Not Recruiting
81
Thu Duc General Hospital ( Site 0881)
Ho Chi Minh City, Vietnam, 700000
Active, Not Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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