Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | ACTIVE NOT_RECRUITING | 600 | — | — | Nov 8, 2023 | Jun 30, 2026 | Apr 2, 2025 | 1 | South Africa |
HIV1-RNA
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Delstrigo |
| Treatment Group 2 | OTHER | KOCITAF |
| Name | Type | Description |
|---|---|---|
| Delstrigo | DRUG | 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 | DRUG | 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. |
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 res...