drugset / Trial / NCT04051970
Reducing Antiretroviral Treatments
Phase 3
Terminated
360 enrolled
ANRS, Emerging Infectious Diseases
Institut National de la Santé Et de la Recherche Médicale, France · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL
Timeline
- Start
- 2019-11-27
- Primary completion
- 2022-06-14
- Completion
- 2022-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biktarvy | Other / unclassified | — | — |
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Genvoya | Unknown | — | — |
| Subject | Lamivudine | Other / unclassified | 300 mg | — |
| Subject | Raltegravir | Other / unclassified | 1200 mg | — |
| Subject | Stribild | Other / unclassified | — | — |
| Subject | Tenofovir | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |
| Subject | tenofovir alafenamide | Small molecule | — | — |