Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

7 août 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Argentine
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentine, C1202ABB
        • Fundación Huésped

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: single arm
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Médicament: ARV treatment
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
Autres noms:
  • tivicay-truvada

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of transgender women retained in care at week 48
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of individuals with HIV RNA undetectable at week 48
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fundación Huésped

Collaborateurs

ViiV Healthcare

Les enquêteurs

  • Chercheur principal: Omar Sued, MD, PhMD, Fundación Huésped

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2015

Achèvement primaire (Réel)

28 juin 2019

Achèvement de l'étude (Réel)

28 juin 2019

Dates d'inscription aux études

Première soumission

18 août 2016

Première soumission répondant aux critères de contrôle qualité

24 janvier 2017

Première publication (Estimation)

27 janvier 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FH-17

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

to publish study results

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner