NCT03033836

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC. The primary objective will be assessed by the proportion of individuals that provide information on ART use and virological outcomes at the end of the study: * Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up. * Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up. 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. The secondary objectives will be evaluated using the following endpoints: 1. Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm; 2. Frequency, type and severity of adverse events and laboratory abnormalities; 3. Pill count, analogue visual scale for adherence in each visit; 4. Changes in the scores of stigma and discrimination scales , quality of life, social support and anxiety and depression (BERGER, WBI,DUKE,CES-D,STAI) at bsl, 4,24, and 48 weeks e;.Changes in the score scales of sexual behaviors, use of drug /alcohol at bsl and at each visit . f. Through association of baseline individual, social and contextual characteristics with percentage of adherence and retention at 48 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	ARV treatment	Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2017-01-27
• Last updated: 2019-08-09

Locations

1 site across 1 country: Argentina