A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
HIV-1-infection
Interventions
DRUG

Delstrigo

Treatment Group 1 Participants will receive Doravirine, as part of a fixed-dose oral combination with lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF, Delstrigo)tablets which are to be administered orally and once daily.

DRUG

KOCITAF

Treatment Group 2 Participants will receive dolutegravir, as part of a fixed-dose oral combination with tenofovir alafenamide plus emtricitabine (DTG/TAF/FTC, KOCITAF) tablets which are to be administered orally and once daily.

Trial Locations (1)

2193

Ezintsha Research Centre, Johannesburg

Sponsors
All Listed Sponsors
collaborator

Africa Health Research Institute

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Professor Francois Venter

OTHER