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ACTIVE NOT RECRUITING
NCT05924438
PHASE3

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

View on ClinicalTrials.gov

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

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.

Locations (1)

Ezintsha Research Centre

Johannesburg, Gauteng, South Africa