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)

• Status: Active, not recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: 4'-ethynyl-2-fluoro-2'-deoxyadenosine; Islatravir

Criteria

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.