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

NCT03033836 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-09

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

ARV treatment

Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Omar Sued, MD, PhMD · Fundacion Huesped

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033836 on ClinicalTrials.gov