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

Study Overview
=================
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 antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample

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

Conditions
-----------------
HIV Seropositivity

Intervention / Treatment
-----------------
* Drug: Biktarvy arm


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study, single arm, multicentric, national
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biktarvy arm<br>one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks | Drug: Biktarvy arm<br>* BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method) |  | virological suppression at Month 6 (M6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) |  | DAY 0 (D0) | 
| proportion of participants with plasma HIV-RNA < 50 copies/ml |  | Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12) | 
| change in CD4 T cell count |  | between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12) | 
| change in CD4/CD8 ratio |  | between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12) | 
| proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir due to (i) Baseline resistance to one of the study drugs, (ii) adverse events leading to study treatment discontinuation/Modification |  | Between DAY 0 (D0) and Month 12 (M12) | 
| proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment) |  | Between DAY 0 (D0) and Month 12 (M12) | 
| proportion of participants with protocol defined virological failure (plasma HIV-RNA > 400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later, or two consecutive plasma HIV-RNA > 50 copies/ml within 15-21 days as of Week 24) |  | Between Month 6 (M6) and Month 12 (M12) | 
| proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure |  | Between Month 6 (M6) and Month 12 (M12) | 
| number of comedications used during the 12-months study period |  | Between DAY 0 (D0) and Month 12 (M12) | 
| adherence to study treatment evaluated by drug concentrations measurement in hair |  | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | 
| proportion of participants lost to follow-up throughout the 12-months study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit) |  | Between DAY 0 (D0) and Month 12 (M12) | 
| participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires |  | At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | 
| adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall), |  | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | 
| adherence to study treatment evaluated by drug concentrations measurement in plasma |  | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | 
| type of comedications used during the 12-months study period |  | Between DAY 0 (D0) and Month 12 (M12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, new diagnosis, Biktarvy