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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    110
  • sponsor
    Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Updated on 24 January 2021
Investigator
AIDA AB BENALYCHERIF
Primary Contact
H pital C te de Nacre - Service des Maladies Infectieuses (0.0 mi away) Contact
+15 other location

Summary

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

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

Details
Condition HIV positive, HIV infection, HIV Infections
Treatment Biktarvy arm
Clinical Study IdentifierNCT03858478
SponsorInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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 HIV immunoassay (ELISA 4th generation) test
antiretroviral-treatment naive
negative urine pregnancy test for women of childbearing potential and willing to use effective 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) in order to be easily reached if needed between Day 0 and Day 7

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 the expected study period
Co-medication with deleterious interaction with study treatment (eg enzyme inducer)
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