drugset / Trial / NCT05924438
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
Phase 3
Active not recruiting
600 enrolled
Professor Francois Venter
Africa Health Research Institute · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-11-08
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doravirine | Small molecule | — | Oral |
| Subject | KOCITAF | Unknown | — | Oral |