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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

HIV Seropositivity

Interventions

Biktarvy armDRUG

BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (17)

Hopital Zobda Quitman

Fort-de-france, Martinique, France

NOT_YET_RECRUITING

Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

Bordeaux, France

Outcomes

Primary Outcomes

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)

Time frame: virological suppression at Month 6 (M6)

Secondary Outcomes

proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)

Time frame: DAY 0 (D0)

proportion of participants with plasma HIV-RNA < 50 copies/ml

Time frame: Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12)

change in CD4 T cell count

Time frame: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)

change in CD4/CD8 ratio

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: Between Month 6 (M6) and Month 12 (M12)

Central Contacts

AIDA AB BENALYCHERIF

CONTACT

+33.1.40.25.63.65 aida.beanlycherif@imea.fr

KARINE KA AMAT

CONTACT

+33.1.40.25.63.52 karine.amat@imea.fr

Data from ClinicalTrials.gov

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