drugset / Trial / NCT05979311
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
Timeline
- Start
- 2024-02-21
- Primary completion
- 2026-04-15
- Completion
- 2027-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | — | Oral |
| Subject | Lamivudine | Other / unclassified | — | Oral |
| Comparator | bictegravir | Small molecule | — | Oral |
| Comparator | emtricitabine | Other / unclassified | — | Oral |
| Comparator | tenofovir alafenamide | Small molecule | — | Oral |