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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033836
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Omar Sued, The Huesped Foundation

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: ARV treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group receiving the same intervention, to evaluate retention at 48 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Study Start Date : December 2015
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019


Arm Intervention/treatment
Experimental: single arm
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Drug: ARV treatment
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
Other Name: tivicay-truvada




Primary Outcome Measures :
  1. Proportion of transgender women retained in care at week 48 [ Time Frame: 48 weeks ]

    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.



Secondary Outcome Measures :
  1. Proportion of individuals with HIV RNA undetectable at week 48 [ Time Frame: 48 weeks ]
    Proportion of patients with HIV-1 RNA levels less than 50 copies/mL at week 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm;

  2. Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality [ Time Frame: From baseline to week 48 ]
    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

  3. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: From baseline to week 48 ]
    Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

  4. Adherence using ACTG form [ Time Frame: From baseline to week 48 ]
    ACTG self report adherence form will be used for baseline and follow up visits

  5. Adherence using analogue visual scale [ Time Frame: From week 4 to week 48 ]
    Analogue visual scale (0-10) will be used at each follow up visit

  6. Adherence by pill count [ Time Frame: From week 4 to week 48 ]
    Pill count of dispensed drugs

  7. Quality of life by QoL Socre and Well being index [ Time Frame: From baseline to week 48 ]
    Changes in the scores of quality of life, will be done through Well-being Index questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .

  8. Patient´s satisfaction with this regimen [ Time Frame: From baseline to week 48 ]
    Changes in the scores of social support,will be done through Duke UNC questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033836


Locations
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Argentina
Fundacion Huesped
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
Sponsors and Collaborators
The Huesped Foundation
ViiV Healthcare
Investigators
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Principal Investigator: Omar Sued, MD, PhMD Fundacion Huesped
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Responsible Party: Omar Sued, PhD, The Huesped Foundation
ClinicalTrials.gov Identifier: NCT03033836    
Other Study ID Numbers: FH-17
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: to publish study results
Keywords provided by Omar Sued, The Huesped Foundation:
transgender women
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors