Clinical Trial

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

Study acronym: Opti-DOR
Active, Not Recruiting Phase 3
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Record status
This record was last updated April 2, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-06-20; most recent amendment 2025-03-27.
Status change: Recruiting → Active, Not Recruiting 2025-03-27
Status change: Not Yet Recruiting → Recruiting 2023-11-10
Trial Details
NCT Number NCT05924438
Lead Sponsor Professor Francois Venter
Collaborators: Africa Health Research Institute, Merck Sharp & Dohme LLC
Conditions HIV-1-infection
Enrollment 600 participants
Start Date 2023-11-08
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-02