NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Merck Sharp & Dohme LLC
Conditions: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Interventions: MK-8527, FTC/TDF, Placebo to MK-8527, Placebo to FTC/TDF
Countries: United States, Argentina, Brazil, Chile, Colombia, Dominican Republic, France, Guatemala
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
Sex: ALL
Age: 16 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Jackson, Mississippi, United States
- Newark, New Jersey, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Greensboro, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Columbia, South Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Bellaire, Texas, United States
- Seattle, Washington, United States
- CABA, Buenos Aires, Argentina
- CABA, Buenos Aires, Argentina
- CABA, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Manaus, Amazonas, Brazil
- Salvador, Estado de Bahia, Brazil
- + 51 more on CT.gov