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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Status and phase

Unknown

Phase 4

Conditions

HIV Seropositivity

Treatments

Drug: Biktarvy arm

Study type

Interventional

Funder types

Other

Identifiers

IMEA 055- FAST

Details and patient eligibility

About

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

Full 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

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)