Overview

Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women

Status:
Completed
Trial end date:
2019-06-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Fundación Huésped
The Huesped Foundation
Collaborator:
ViiV Healthcare
Treatments:
Dolutegravir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine
Tenofovir