At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults
In Brief
A Phase 2 clinical trial evaluating Islatravir, Placebo to Islatravir, and 7 other interventions for HIV-1 Infection. Completed, enrolled 123 participants across 26 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks