Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
HIV, HIV Pre-exposure Prophylaxis
About this trial
This is an interventional prevention trial for HIV
Eligibility Criteria
Inclusion Criteria: Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization Has low-risk of HIV infection Males: if capable of producing sperm, the participant agrees to the following during the intervention period and for ≥8 weeks after the last dose of study intervention: abstains from penile-vaginal intercourse OR uses approved contraception unless confirmed to be azoospermic. Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception or is abstinent from penile-vaginal intercourse Exclusion Criteria: Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA]) Prior use of MK-8527 or islatravir (MK-8591)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
MK-8527 Low Dose QM
MK-8527 Medium Dose QM
MK-8527 High Dose QM
Placebo to MK-8527
Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.