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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
Sponsor: Professor Francois Venter
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.
Official title: Opti-DOR: 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2023-11-08
Completion Date
2026-06-30
Last Updated
2025-04-02
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Ezintsha Research Centre
Johannesburg, Gauteng, South Africa