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

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

March 4, 2016

Primary Completion Date

August 14, 2018

Study Completion Date

February 7, 2024

Conditions
HIV-1Central Nervous System
Interventions
DRUG

Doravirine, Tenofovir, Lamivudine - Blinded

A single tablet FDC containing doravirine 100 mg, lamivudine (3TC) 300 mg and tenofovir disoproxil fumarate (TDF) 300 mg administered orally, once daily for 12 weeks during the Blinded period

DRUG

Doravirine, Tenofovir, Lamivudine - Open-Label

A single-tablet FDC containing doravirine 100 mg, 3TC 300 mg and TDF 300 mg administered orally, once daily for either 12 or 24 weeks during the Open-Label Period; also an additional 96 weeks during the Open-Label extension period 1; a maximum total duration of treatment of 228 weeks during the Open-Label extension period 2; and a maximum total duration of treatment of 324 weeks during the Open-Label extension period 3.

DRUG

ATRIPLA^TM

A single tablet FDC containing efavirenz (EFV) 600 mg, emtricitabine (FTC) 200 mg, and TDF 300 mg administered orally, once daily for 12 weeks during the Blinded period

DRUG

Placebo to ATRIPLA™

A single placebo to ATRIPLA™ tablet administered orally, once daily for 12 weeks during the Blinded period

DRUG

Placebo to Doravirine, Tenofovir, Lamivudine

A single placebo to doravirine, tenofovir, lamivudine tablet administered orally, once daily for 12 weeks during the Blinded period

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02652260 - Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) | Biotech Hunter | Biotech Hunter