drugset / Trial / NCT03033836
Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
NaSingle-groupOpen-labelTreatment
Summary
Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW). The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC or 3TC Secondary objectives: * To evaluate the efficacy of the antiretroviral regimen at week 48 ; * To describe the safety and tolerability of this regimen; * To evaluate adherence across 48 weeks; * To determine the patient satisfaction with this regimen; * To identify individual, social and contextual factors associated with adherence and retention.
Timeline
- Start
- 2015-12
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Tenofovir | Small molecule | 300 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |