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

Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

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

• 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

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)