HIV InfectionsPhase 4TRANSViiVNCT03033836

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

A Phase 4 study testing ARV treatment in people with HIV Infections, run by Fundación Huésped at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HIV Infections
What is being tested?: ARV treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteArgentina
Study dates: Dec 2015to 28 Jun 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Fundacion Huesped
Ciudad de Buenos Aires, Buenos Aires, C1202ABB

Other trials in Argentina

About this study

Official title: Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women

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.

Read the 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 .
Through association of baseline individual, social and contextual characteristics with percentage of adherence and retention at 48 weeks.

Conditions: HIV Infections
Being tested: ARV treatment
Keywords: transgender women
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARV treatmentDrug
Also called tivicay-truvada
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.

Study groups in NCT03033836
Study group	Role	What they receive
single arm	Experimental	ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine Receives: Drug: ARV treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 48 weeks

Secondary outcomes (8)

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;
Measured: 48 weeks
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.
Measured: From baseline to week 48
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.
Measured: From baseline to week 48
Adherence using ACTG form
ACTG self report adherence form will be used for baseline and follow up visits
Measured: From baseline to week 48
Adherence using analogue visual scale
Analogue visual scale (0-10) will be used at each follow up visit
Measured: From week 4 to week 48
Adherence by pill count
Pill count of dispensed drugs
Measured: From week 4 to week 48
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 .
Measured: From baseline to 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 .
Measured: From baseline to week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201528 Jun 2019

First posted27 Jan 2017 (estimated)
Study startDec 2015
Primary completion28 Jun 2019
Study completion28 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group receiving the same intervention, to evaluate retention at 48 weeks
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03033836
Sponsor's protocol ID: FH-17
Acronym: TRANSViiV
Status last verified: Aug 2019
First submitted: 18 Aug 2016
Last updated: 9 Aug 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: to publish study results

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
ClinicalTrials.gov ID: NCT03033836
Acronym / sponsor ID: TRANSViiV / FH-17
Conditions: HIV Infections
Keywords: transgender women
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Fundación HuéspedUniversity, hospital or other
Collaborators: ViiV Healthcare
Study start: Dec 2015
Primary completion: 28 Jun 2019 (actual)
Study completion: 28 Jun 2019 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 .
Through association of baseline individual, social and contextual characteristics with percentage of adherence and retention at 48 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group receiving the same intervention, to evaluate retention at 48 weeks

Arm	Type	Receives
single arm	Experimental	Drug: ARV treatmentARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARV treatmentAlso: tivicay-truvadaDolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.	Drug	single arm

Primary outcome

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.

8 secondary outcomes

Proportion of individuals with HIV RNA undetectable at week 48
Time frame: 48 weeks
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Time frame: From baseline to week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: From baseline to week 48
Adherence using ACTG form
Time frame: From baseline to week 48
Adherence using analogue visual scale
Time frame: From week 4 to week 48
Adherence by pill count
Time frame: From week 4 to week 48
Quality of life by QoL Socre and Well being index
Time frame: From baseline to week 48
Patient´s satisfaction with this regimen
Time frame: From baseline to week 48

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
Individual participant dataSharing planned: Yes. to publish study results

Related trials for HIV Infections

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omar Sued, MD, PhMD principal investigator

Fundacion Huesped

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ARV treatment in people with HIV Infections, run by Fundación Huésped at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of transgender women retained in care at week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.