NCT02397096View on ClinicalTrials.gov

Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)

PHASE3CompletedINTERVENTIONAL
Enrollment

673

Participants

Timeline

Start Date

June 9, 2015

Primary Completion Date

February 22, 2018

Study Completion Date

September 5, 2023

Conditions
HIV-1 Infection
Interventions
DRUG

Doravirine, Tenofovir, Lamivudine

Single tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg

DRUG

Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor

Baseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the product circular

DRUG

Baseline regimen of cobicistat-boosted elvitegravir

Baseline regimen of antiretroviral therapy with cobicistat-boosted elvitegravir administered according to the product circular

DRUG

Baseline regimen of a non-nucleoside reverse transcriptase inhibitor

Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular

DRUG

Baseline regimen of two nucleoside reverse transcriptase inhibitors

Baseline regimen of antiretroviral therapy with two NRTIs administered according to the product circular

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02397096 - Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) | Biotech Hunter | Biotech Hunter