Clinical trial NCT03033836: Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Official title: Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: transgender women
Lead sponsor: Fundación Huésped
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2017-01-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group receiving the same intervention, to evaluate retention at 48 weeks
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of transgender women retained in care at week 48
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of individuals with HIV RNA undetectable at week 48
timeFrame: 48 weeks
measure: Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
timeFrame: From baseline to week 48
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: From baseline to week 48
measure: Adherence using ACTG form
timeFrame: From baseline to week 48
measure: Adherence using analogue visual scale
timeFrame: From week 4 to week 48
measure: Adherence by pill count
timeFrame: From week 4 to week 48
measure: Quality of life by QoL Socre and Well being index
timeFrame: From baseline to week 48
measure: Patient´s satisfaction with this regimen
timeFrame: From baseline to week 48
Other outcomes:
Locations:
city: Ciudad de Buenos Aires
country: Argentina
facility: Fundacion Huesped
state: Buenos Aires
Study officials:
affiliation: Fundacion Huesped
name: Omar Sued, MD, PhMD
role: PRINCIPAL_INVESTIGATOR
References: