Status:
UNKNOWN
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
Lead Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Conditions:
HIV Seropositivity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
Detailed 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 antiretrov...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03858478
Start Date
November 18 2019
End Date
December 31 2021
Last Update
January 9 2020
Active Locations (17)
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1
Hopital Zobda Quitman
Fort-de-france, Martinique, France, 97261
2
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, France, 33000
3
Hôpital Côte de Nacre - Service des Maladies Infectieuses
Caen, France, 14033
4
Centre hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106