A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Recruiting · NCT07044297 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
FTC/TDFMK-8527Placebo to FTC/TDFPlacebo to MK-8527
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 as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The main inclusion criteria include but are not limited to the following:
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
- Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
- 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 anal or cervical cancers
- 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
- Is expecting to donate eggs at any time during the study
Where it is running
60 locations listed across 16 US states.
- University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) - Birmingham, Alabama, United States
- USA Health University Hospitals ( Site 0020) - Mobile, Alabama, United States
- UCLA Center for Clinical AIDS Research and Education ( Site 0004) - Los Angeles, California, United States
- Bridge HIV - San Francisco Department of Public Health ( Site 0001) - San Francisco, California, United States
- Whitman-Walker Institute ( Site 0016) - Washington D.C., District of Columbia, United States
- University of Miami RAPID Research ( Site 0003) - Miami, Florida, United States
- Orlando Immunology Center ( Site 0021) - Orlando, Florida, United States
- Hope Clinic of the Emory Vaccine Center ( Site 0009) - Decatur, Georgia, United States
- University of Illinois Chicago ( Site 0027) - Chicago, Illinois, United States
- University Medical Center New Orleans ( Site 0024) - New Orleans, Louisiana, United States
- Open Arms Healthcare Center ( Site 0025) - Jackson, Mississippi, United States
- Rutgers New Jersey Medical School ( Site 0010) - Newark, New Jersey, United States
- Montefiore Medical Center ( Site 0017) - The Bronx, New York, United States
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) - Chapel Hill, North Carolina, United States
- Regional Center for Infectious Diseases ( Site 0018) - Greensboro, North Carolina, United States
- Philadelphia Fight Community Health Centers ( Site 0011) - Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) - Pittsburgh, Pennsylvania, United States
- Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007) - Columbia, South Carolina, United States
- St. Jude Children's Research Hospital ( Site 0026) - Memphis, Tennessee, United States
- Meharry Medical College ( Site 0013) - Nashville, Tennessee, United States
- Central Texas Clinical Research ( Site 0014) - Austin, Texas, United States
- Saint Hope Foundation, Inc. ( Site 0015) - Bellaire, Texas, United States
- Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002) - Seattle, Washington, United States
- Fundación IDEAA ( Site 0351) - Buenos Aires, Argentina
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051) - Guatemala City, Guatemala
- MEDI-K ( Site 1053) - Guatemala City, Guatemala
- CELAN,S.A ( Site 1052) - Guatemala City, Guatemala
- Thu Duc General Hospital ( Site 0881) - Ho Chi Minh City, Vietnam
- Nyanza Reproductive Health Society ( Site 0200) - Kisumu, Kenya
- Impact Research and Development Organisation (IRDO) ( Site 0202) - Kisumu, Kenya
- Universiti Malaya Medical Centre ( Site 0651) - Kuala Lumpur, Malaysia
- Via Libre ( Site 0551) - Lima, Peru
- Policlínico Socios en Salud ( Site 0557) - Lima, Peru
- Investigaciones Medicas en Salud ( Site 0552) - Lima, Peru
- Asociación Civil Impacta Salud y Educación ( Site 0553) - Lima, Peru
- Universidad Nacional Mayor De San Marcos ( Site 0555) - Lima, Peru
- Hopital Saint Louis ( Site 0100) - Paris, France
- Hôpital Tenon ( Site 0102) - Paris, France
- Instituto Nacional de Infectologia Evandro Chagas ( Site 0407) - Rio de Janeiro, Brazil
- Checkpoint Zurich ( Site 1100) - Zurich, Switzerland
- Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412) - Manaus, Amazonas, Brazil
- IPS SURA San Diego ( Site 0500) - Medellín, Antioquia, Colombia
- Hospital Dr. Hernán Henríquez Aravena ( Site 0451) - Temuco, Araucania, Chile
- Clinica de la Costa S.A.S. ( Site 0501) - Barranquilla, Atlántico, Colombia
- Chulalongkorn Hospital ( Site 0807) - Bangkok, Bangkok, Thailand
- HIV Netherlands Australia Thailand Research Collaboration ( Site 0808) - Bangkok, Bangkok, Thailand
- Institute of HIV Research and Innovation ( Site 0810) - Bangkok, Bangkok, Thailand
- Faculty of Medicine Siriraj Hospital ( Site 0806) - Bangkok, Bangkok, Thailand
- Hospital Universitario San Ignacio ( Site 0503) - Bogotá, Bogota D.C., Colombia
- Centro de Estudios Infectológicos S.A. ( Site 0357) - CABA, Buenos Aires, Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352) - CABA, Buenos Aires, Argentina
- Fundación Huésped ( Site 0350) - CABA, Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353) - Mar del Plata, Buenos Aires, Argentina
- University Hospital Basel ( Site 1102) - Basel, Canton of Basel-City, Switzerland
- Inselspital Bern ( Site 1103) - Bern, Canton of Bern, Switzerland
- Research Institute for Health Sciences ( Site 0809) - Muang, Chiang Mai, Thailand
- Foundation For Professional Development ( Site 0257) - King Williams Town, Eastern Cape, South Africa
- Obras Sociais Irma Dulce ( Site 0406) - Salvador, Estado de Bahia, Brazil
- Wits RHI Research Center ( Site 0251) - Johannesburg, Gauteng, South Africa
- Setshaba Research Centre ( Site 0252) - Pretoria, Gauteng, South Africa
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →