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

HIV Seropositivity Clinical Trial

— FAST  

Official title:

Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858478
• Other study ID #: IMEA 055- FAST
• Status: Recruiting
• Phase: Phase 4
• 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
• 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)

Related Conditions & MeSH terms

• HIV Seropositivity

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)