HIV Seropositivity Clinical Trial
— FASTOfficial title:
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France
Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses | Bordeaux | |
France | Hôpital Côte de Nacre - Service des Maladies Infectieuses | Caen | |
France | Centre hospitalier Sud Francilien | Corbeil-Essonnes | |
France | Hôpital Henri Mondor - Service d'Immunologie Clinique | Créteil | |
France | Hopital Francois Mitterrand | Dijon | |
France | Hopital Zobda Quitman | Fort-de-france | Martinique |
France | Hopital Raymond Poincare | Garches | |
France | Hopital Sainte-Marguerite | Marseille | |
France | Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales | Montpellier | |
France | L'ARCHET | Nice | |
France | Hopital Bichat | Paris | |
France | Hopital Necker | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Hopital Tenon | Paris | |
France | Hopital Foch | Suresnes | |
France | Hopital Gustave Dron | Tourcoing | |
France | Hopital Bretonneau | Tours |
Lead Sponsor | Collaborator |
---|---|
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) | DAY 0 (D0) | ||
Secondary | 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) | ||
Secondary | change in CD4 T cell count | between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12) | ||
Secondary | change in CD4/CD8 ratio | between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | number of comedications used during the 12-months study period | Between DAY 0 (D0) and Month 12 (M12) | ||
Secondary | adherence to study treatment evaluated by drug concentrations measurement in hair | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | adherence to study treatment evaluated by drug concentrations measurement in plasma | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) | ||
Secondary | type of comedications used during the 12-months study period | Between DAY 0 (D0) and Month 12 (M12) |
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