drugset / Trial / NCT02652260

Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)

NCT02652260

Phase 2 Completed 86 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study aims to evaluate a switch from fixed dose combination (FDC) treatment with ATRIPLA\^TM for 12 weeks prior to screening to FDC treatment with Doravirine, Tenofovir, Lamivudine (MK-1439A) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. The primary hypothesis is that switching from ATRIPLA\^TM to Doravirine, Tenofovir, Lamivudine results in a lower proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at Week 12 than continuation of ATRIPLA\^TM treatment.

Timeline

Start
2016-03-04
Primary completion
2018-08-14
Completion
2024-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Doravirine Small molecule 100 mg Oral
Subject Efavirenz Other / unclassified 600 mg Oral
Subject Lamivudine Other / unclassified 300 mg Oral
Subject Tenofovir Small molecule 300 mg Oral
Subject emtricitabine Other / unclassified 200 mg Oral