Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST

Last updated: January 6, 2020
Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Overall Status: Active - Recruiting

Phase

4

Condition

Hiv/aids

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT03858478
IMEA 055- FAST
  • Ages > 18
  • All Genders

Study Summary

Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 18 years

  • newly diagnosed HIV-infected individual evidenced by any of the following tests: (i)positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIVimmunoassay (ELISA 4th generation) test

  • antiretroviral-treatment naive

  • negative urine pregnancy test for women of childbearing potential and willing to useeffective contraception (mechanical or medicamental)

  • willing to sign an informed written consent-

  • regular health insurance

  • willing to provide two distinct contact information (telephone number and/or email) inorder to be easily reached if needed between Day 0 and Day 7

Exclusion

Exclusion Criteria:

  • clinical symptoms suggestive of opportunistic infections

  • participant not willing to provide two distinct contact information

  • a woman who is pregnant or breast-feeding or planning to become pregnant during theexpected study period.

  • Co-medication with deleterious interaction with study treatment (eg enzyme inducer)

Study Design

Total Participants: 110
Study Start date:
November 18, 2019
Estimated Completion Date:
December 31, 2021

Study Description

  • Patient treated at the first clinical contact

  • 18 sites (hospitals) in France

  • Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA < 50 copies/ml)

  • Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample

Connect with a study center

  • Hopital Zobda Quitman

    Fort-de-france, Martinique 97261
    France

    Site Not Available

  • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hôpital Côte de Nacre - Service des Maladies Infectieuses

    Caen, 14033
    France

    Active - Recruiting

  • Centre hospitalier Sud Francilien

    Corbeil-Essonnes, 91106
    France

    Site Not Available

  • Hôpital Henri Mondor - Service d'Immunologie Clinique

    Créteil, 94010
    France

    Active - Recruiting

  • Hopital Francois Mitterrand

    Dijon, 21034
    France

    Active - Recruiting

  • Hopital Raymond Poincare

    Garches, 92380
    France

    Active - Recruiting

  • Hopital Sainte-Marguerite

    Marseille, 13274
    France

    Site Not Available

  • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

    Montpellier, 34000
    France

    Site Not Available

  • L'ARCHET

    Nice, 06200
    France

    Site Not Available

  • Hopital Bichat

    Paris, 75018
    France

    Active - Recruiting

  • Hopital Necker

    Paris, 75015
    France

    Active - Recruiting

  • Hopital Saint Antoine

    Paris, 75012
    France

    Active - Recruiting

  • Hopital Tenon

    Paris, 75020
    France

    Active - Recruiting

  • Hopital Foch

    Suresnes, 92150
    France

    Active - Recruiting

  • Hopital Gustave Dron

    Tourcoing, 59208
    France

    Active - Recruiting

  • Hopital Bretonneau

    Tours, 37044
    France

    Site Not Available

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