Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Conditions
Brief summary
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
Interventions
DRUGMK-8527
Oral tablet
DRUGFTC/TDF
Oral tablet
Placebo tablet matched to MK-8527
Placebo tablet matched to FTC/TDF
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection | Up to approximately 2 years | The number of participants with adjudicated HIV-1 infection will be determined. |
| Number of Participants Who Experience At Least One Adverse Event (AE) | Up to approximately 2 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 2 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported. |
Countries
Argentina, Brazil, Chile, Colombia, Dominican Republic, France, Guatemala, Malaysia, Peru, Philippines, South Africa, Switzerland, Thailand, United States, Vietnam
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed