drugset / Trial / NCT03033836

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

NCT03033836

Phase 4 Completed 60 enrolled Fundación Huésped ViiV Healthcare · collab
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

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg
Subject Tenofovir Small molecule 300 mg
Subject emtricitabine Other / unclassified 200 mg