Back to resultsDolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women (TRANSViiV)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
ARV treatment
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring transgender women
Eligibility Criteria
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.
Sites / Locations
- Fundacion Huesped
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of individuals with HIV RNA undetectable at week 48
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;
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
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.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
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.
Adherence using ACTG form
ACTG self report adherence form will be used for baseline and follow up visits
Adherence using analogue visual scale
Analogue visual scale (0-10) will be used at each follow up visit
Adherence by pill count
Pill count of dispensed drugs
Quality of life by QoL Socre and Well being index
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 .
Patient´s satisfaction with this regimen
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 .
Full Information
NCT ID
NCT03033836
First Posted
August 18, 2016
Last Updated
August 7, 2019
Sponsor
Fundación Huésped
Collaborators
ViiV Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03033836
Brief Title
Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Acronym
TRANSViiV
Official Title
Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Huésped
Collaborators
ViiV Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
transgender women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single Group receiving the same intervention, to evaluate retention at 48 weeks
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Intervention Type
Drug
Intervention Name(s)
ARV treatment
Other Intervention Name(s)
tivicay-truvada
Intervention Description
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
Primary Outcome Measure Information:
Title
Proportion of transgender women retained in care at week 48
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of individuals with HIV RNA undetectable at week 48
Description
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;
Time Frame
48 weeks
Title
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Description
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.
Time Frame
From baseline to week 48
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Description
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.
Time Frame
From baseline to week 48
Title
Adherence using ACTG form
Description
ACTG self report adherence form will be used for baseline and follow up visits
Time Frame
From baseline to week 48
Title
Adherence using analogue visual scale
Description
Analogue visual scale (0-10) will be used at each follow up visit
Time Frame
From week 4 to week 48
Title
Adherence by pill count
Description
Pill count of dispensed drugs
Time Frame
From week 4 to week 48
Title
Quality of life by QoL Socre and Well being index
Description
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 .
Time Frame
From baseline to week 48
Title
Patient´s satisfaction with this regimen
Description
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 .
Time Frame
From baseline to week 48
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Sued, MD, PhMD
Organizational Affiliation
Fundacion Huesped
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Huesped
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1202ABB
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
to publish study results
Learn more about this trial
Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
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