Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

• Status: Active, not recruiting
• Trial end date: 2022-03-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Islatravir; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• Has HIV-1 infection

• Is naïve to anti-retroviral therapy (ART).

• Is clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study

• Female is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP); but if WOCBP agrees to follow the contraceptive guidance

• All participants, male and female, agree to use barrier methods of contraception when engaged in any sexual activity during treatment and for 6 weeks following treatment.

Exclusion Criteria:

• Is a user of recreational or illicit drugs or has had a history of drug or alcohol abuse or dependence that may interfere with trial participation

• Has significant hypersensitivity or other contraindication to any of the components of the study drugs

• Has a history of malignancy ≤5 years prior

• Female expects to donate eggs at any time during the study

• Is breastfeeding or expecting to conceive

• A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment

• Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1

• Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study

• Requires any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan, Nafcillin, Pentostatin

• Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial

• Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor

• Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV co-infection defined as hepatitis B surface antigen [HBsAg]-positive

• Has a current (active) diagnosis of acute hepatitis due to any cause

• Has previously been randomized in a study and received islatravir (MK-8591), DOR, Doravirine, Tenofovir, Lamivudine, or 3TC.