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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Treatments: Anti-Retroviral Agents; Emtricitabine; Tenofovir

Criteria

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)