Overview

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.