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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba17 sites in 1 country110 target enrollmentNovember 18, 2019

ConditionsHIV Seropositivity

InterventionsBiktarvy arm

DrugsBiktarvy arm

Overview

Phase: Phase 4
Intervention: Biktarvy arm
Conditions: HIV Seropositivity
Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Enrollment: 110
Locations: 17
Primary Endpoint: 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)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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

Registry

clinicaltrials.gov

Start Date

November 18, 2019

End Date

December 31, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

Biktarvy arm

one tablet of BIKTARVY including \[TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) \] one tablet once a day for 48 weeks

Intervention: Biktarvy arm

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)(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))
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))