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

7 agosto 2019 aggiornato da: Omar Sued, Fundación Huésped

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
        • Fundacion Huesped

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: single arm
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Droga: ARV treatment
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
Altri nomi:
  • tivicay-truvada

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of transgender women retained in care at week 48
Lasso di tempo: 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.
48 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of individuals with HIV RNA undetectable at week 48
Lasso di tempo: 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;
48 weeks
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Lasso di tempo: 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.
From baseline to week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Lasso di tempo: 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.
From baseline to week 48
Adherence using ACTG form
Lasso di tempo: From baseline to week 48
ACTG self report adherence form will be used for baseline and follow up visits
From baseline to week 48
Adherence using analogue visual scale
Lasso di tempo: From week 4 to week 48
Analogue visual scale (0-10) will be used at each follow up visit
From week 4 to week 48
Adherence by pill count
Lasso di tempo: From week 4 to week 48
Pill count of dispensed drugs
From week 4 to week 48
Quality of life by QoL Socre and Well being index
Lasso di tempo: 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 .
From baseline to week 48
Patient´s satisfaction with this regimen
Lasso di tempo: 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 .
From baseline to week 48

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fundación Huésped

Collaboratori

ViiV Healthcare

Investigatori

  • Investigatore principale: Omar Sued, MD, PhMD, Fundacion Huesped

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2015

Completamento primario (Effettivo)

28 giugno 2019

Completamento dello studio (Effettivo)

28 giugno 2019

Date di iscrizione allo studio

Primo inviato

18 agosto 2016

Primo inviato che soddisfa i criteri di controllo qualità

24 gennaio 2017

Primo Inserito (Stima)

27 gennaio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FH-17

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

to publish study results

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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