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

• Status: Completed
• Trial end date: 2019-06-28
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Huésped; The Huesped Foundation
• Collaborator: ViiV Healthcare
• Treatments: Dolutegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

1. HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.

2. 18 years and older.

3. Self-identified as TGW

4. ART naïve.

5. Written informed consent provided.

Exclusion Criteria:

1. Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.

2. Alcohol or drug use that might affect adherence.

3. Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs containing Ca++ and or Mg++ at study entry.

4. Opportunistic infection (CDC "C" category) or other disease and/or clinical conditions that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.

5. Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the investigational product.

6. Contraindication to any of the study drugs (history of renal diseases, lab abnormalities grade 4 or any other clinical condition prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements).

7. Anticipated need for Hepatitis C virus (HCV) therapy during the study.

8. Creatinine clearance of <50 mL/min via Cockroft-Gault method.

9. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.