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 Transcrip

• Status: Active, not recruiting
• Trial end date: 2023-08-26

Summary

The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.

• Phase: Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Cobicistat; Darunavir; Efavirenz; Elvitegravir; HIV Protease Inhibitors; Lamivudine; Lopinavir; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Rilpivirine; Ritonavir; Tenofovir