Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

August 8, 2019

Primary Completion Date

April 26, 2022

Study Completion Date

October 27, 2022

Conditions
HIV Infections
Interventions
DRUG

Dolutegravir 50 mg

Tenofovir-lamivudine-dolutegravir fixed-dose combination tablet with a lead-in supplementary dose of 50 mg dolutegravir taken 12 hours later for the first 14 days, with continuation of tenofovir-lamivudine-dolutegravir for the duration of the study (48 weeks).

DRUG

Placebo

Tenofovir-lamivudine-dolutegravir fixed-dose combination tablet with a matching placebo taken 12 hours later for the first 14 days, with continuation of tenofovir-lamivudine-dolutegravir for the duration of the study (48 weeks).

Trial Locations (1)

8001

Khayelitsha Site B/Ubuntu Community Health Clinic, Cape Town

All Listed Sponsors
collaborator

Wellcome Trust

OTHER

collaborator

Médecins Sans Frontières, Belgium

OTHER

lead

University of Cape Town

OTHER

NCT03991013 - Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial | Biotech Hunter | Biotech Hunter