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

NCT03033836 | Completed Phase 4

• 1 other identifier: FH-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

transgender women

Outcome Measures

Primary Outcomes (1)

• Proportion of transgender women retained in care at week 48

  Proportion of enrolled and dosed individuals that complete protocol defined visits during 48 weeks of follow up. 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.

  48 weeks

Secondary Outcomes (8)

• Proportion of individuals with HIV RNA undetectable at week 48

  48 weeks

• Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

  From baseline to week 48

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events

  From baseline to week 48

• Adherence using ACTG form

  From baseline to week 48

• Adherence using analogue visual scale

  From week 4 to week 48

Study Arms (1)

single arm

EXPERIMENTAL

ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine

Drug: ARV treatment

Interventions

ARV treatment DRUG

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

Also known as: tivicay-truvada

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Huésped: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Fundacion Huesped

Ciudad de Buenos Aires, Buenos Aires, C1202ABB, Argentina

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Omar Sued, MD, PhMD

  Fundacion Huesped

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Single Group receiving the same intervention, to evaluate retention at 48 weeks

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: January 27, 2017
• Study Start: December 1, 2015
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)