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

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, randomised, phase 3, two-arm study conducted over 96 weeks.

The study includes a screening period day - 60 to -1, enrolment visit day 0, and a 96-week treatment follow-up period.

Approximately 600 male and female participants infected with HIV-1 eligible for first-line therapy, will be randomly assigned in a 1:1 ratio approximately 300 participants per treatment group to either Treatment Group 1 DOR/3TC/TDF or Treatment Group 2 DTG/TAF/FTC. All medications will be administered in an open label design.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Professor Francois Venter
• Collaborators: Africa Health Research Institute; Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

Each participant must meet all the following criteria to be enrolled in this study.

• ≥18 years old, male or female.

• Documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked immunosorbent assay HIV-1 antibody test) at screening, with no baseline DOR resistance (please see Table 2 below).

• Is ART naïve.

• BMI≥ 25 kg/cm2.

• VL >500 copies/ml.

• Must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.

• Female participants of childbearing potential (WOCBP) are eligible to participate if willing to use highly effective contraception methods from enrolment, for the duration of the study.

Exclusion criteria:

Participants meeting any of the following criteria will be excluded from the study:

• Is currently participating in any other interventional study or participated in a study with an investigational drug within 60 days of screening.

• Is pregnant, breastfeeding or intends to become pregnant or breastfeed during the study.

• Has active TB co-infection and requires anti-TB treatment.

• Has unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); Child-Pugh C.

• Has pre-existing physical or mental condition (including substance abuse disorder and suicide risk) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.

• Clinically unstable in the investigator's opinion (any pre-existing medical or laboratory abnormalities must be deemed to be stable by the investigator prior to study enrolment).

• Has estimated creatinine clearance <60mL/min per Cockcroft-Gault formula.

• Is taking, and is unable to discontinue, any of the following prohibited medications:

carbamazepine, oxcarbazepine, phenobarbital, phenytoin; the antimycobacterial rifampicin, rifapentine; St. John's Wort (Hypericum perforatum); mitotane; enzalutamide; lumacaftor.