Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST

Phase 1

• Conditions: HIV positive age > 18 years -newly diagnosed HIV-infected individual evidenced by any tests -antiretroviral-treatment naive -negative urine pregnancy test -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; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-000812-27-FR
• Lead Sponsor: IMEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 110

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified