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

Phase 4

• Conditions: HIV Seropositivity
• Interventions: Drug: Biktarvy arm

• Registration Number: NCT03858478
• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Status Verified: 2019-11
• Study Start: 2019-11-18
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09
• Primary Completion: 2021-03-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• 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

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biktarvy arm	Biktarvy arm	one tablet of BIKTARVY including \[TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) \] one tablet once a day for 48 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)	DAY 0 (D0)
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)
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)
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)
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)
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)

Trial Locations

Locations (17)

Hopital Raymond Poincare; 🇫🇷 Garches, France

Hôpital Henri Mondor - Service d'Immunologie Clinique; 🇫🇷 Créteil, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Francois Mitterrand; 🇫🇷 Dijon, France

Hopital Bichat; 🇫🇷 Paris, France

Hopital Sainte-Marguerite; 🇫🇷 Marseille, France

Hopital Gustave Dron; 🇫🇷 Tourcoing, France

Hopital Bretonneau; 🇫🇷 Tours, France

Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses; 🇫🇷 Bordeaux, France

Centre hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Hopital Tenon; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France

Hopital Zobda Quitman; 🇫🇷 Fort-de-france, Martinique, France

Hôpital Côte de Nacre - Service des Maladies Infectieuses; 🇫🇷 Caen, France

Hopital Necker; 🇫🇷 Paris, France

Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales; 🇫🇷 Montpellier, France

L'ARCHET; 🇫🇷 Nice, France