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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03858478
Other study ID # IMEA 055- FAST
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 18, 2019
Est. completion date December 31, 2021

Study information

Verified date November 2019
Source Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Contact AIDA AB BENALYCHERIF
Phone +33.1.40.25.63.65
Email aida.beanlycherif@imea.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France


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


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Country where clinical trial is conducted

France, 

Outcome

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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