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Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy arm | Experimental | one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy arm | Drug | BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Zobda Quitman | Not yet recruiting | Fort-de-france | Martinique | 97261 | France |
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Pilot study, single arm, multicentric, national
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| 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) |
| Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses | Recruiting | Bordeaux | 33000 | France |
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| Hôpital Côte de Nacre - Service des Maladies Infectieuses | Recruiting | Caen | 14033 | France |
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| Centre hospitalier Sud Francilien | Not yet recruiting | Corbeil-Essonnes | 91106 | France |
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| Hôpital Henri Mondor - Service d'Immunologie Clinique | Recruiting | Créteil | 94010 | France |
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| Hopital Francois Mitterrand | Recruiting | Dijon | 21034 | France |
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| Hopital Raymond Poincare | Recruiting | Garches | 92380 | France |
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| Hopital Sainte-Marguerite | Not yet recruiting | Marseille | 13274 | France |
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| Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales | Not yet recruiting | Montpellier | 34000 | France |
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| L'ARCHET | Not yet recruiting | Nice | 06200 | France |
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| Hopital Saint Antoine | Recruiting | Paris | 75012 | France |
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| Hopital Necker | Recruiting | Paris | 75015 | France |
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| Hopital Bichat | Recruiting | Paris | 75018 | France |
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| Hopital Tenon | Recruiting | Paris | 75020 | France |
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| Hopital Foch | Recruiting | Suresnes | 92150 | France |
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| Hopital Gustave Dron | Recruiting | Tourcoing | 59208 | France |
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| Hopital Bretonneau | Not yet recruiting | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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