Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Sponsored by Merck Sharp & Dohme LLC
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Is in general good health with acceptable laboratory values at screening
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
- Use contraceptives consistent with local regulations
- Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
- A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.
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
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day 1 through the duration of the study.
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
- Has previously been randomized in a study and received islatravir (MK-8591).
- Female is expecting to conceive or donate eggs at any time during the study
- Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for females) or deemed clinically abnormal by the investigator.