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

NCT ID: NCT03033836

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-06-28

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine

Group Type: EXPERIMENTAL

ARV treatment

Intervention Type: DRUG

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

Interventions

ARV treatment

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

Intervention Type: DRUG

Other Intervention Names

tivicay-truvada

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

Fundación Huésped

OTHER

Sponsor Role: lead

Responsible Party

Omar Sued

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Sued, MD, PhMD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Huesped

Locations

Fundacion Huesped

Ciudad de Buenos Aires, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

FH-17

Identifier Type: -

Identifier Source: org_study_id