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

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:

• 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;
• Frequency, type and severity of adverse events and laboratory abnormalities;
• Pill count, analogue visual scale for adherence in each visit;
• 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.

Inclusion criteria

• 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.
• 18 years and older.
• Self-identified as TGW
• ART naïve.
• Written informed consent provided.

Exclusion criteria

• Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.
• Alcohol or drug use that might affect adherence.
• 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.
• 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.
• 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.
• 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).
• Anticipated need for Hepatitis C virus (HCV) therapy during the study.
• Creatinine clearance of <50 mL/min via Cockroft-Gault method.
• Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.