Clinical trial NCT03858478: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
Official title: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Seropositivity
Keywords: HIV, new diagnosis, Biktarvy
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study, single arm, multicentric, national
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: 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)
timeFrame: virological suppression at Month 6 (M6)
Secondary outcomes:
measure: proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)
timeFrame: DAY 0 (D0)
measure: proportion of participants with plasma HIV-RNA < 50 copies/ml
timeFrame: Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12)
measure: change in CD4 T cell count
timeFrame: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)
measure: change in CD4/CD8 ratio
timeFrame: between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12)
measure: 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
timeFrame: Between DAY 0 (D0) and Month 12 (M12)
measure: proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)
timeFrame: Between DAY 0 (D0) and Month 12 (M12)
measure: 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)
timeFrame: Between Month 6 (M6) and Month 12 (M12)
measure: proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure
timeFrame: Between Month 6 (M6) and Month 12 (M12)
measure: number of comedications used during the 12-months study period
timeFrame: Between DAY 0 (D0) and Month 12 (M12)
measure: adherence to study treatment evaluated by drug concentrations measurement in hair
timeFrame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)
measure: 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)
timeFrame: Between DAY 0 (D0) and Month 12 (M12)
measure: participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires
timeFrame: At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12)
measure: adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall),
timeFrame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)
measure: adherence to study treatment evaluated by drug concentrations measurement in plasma
timeFrame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)
measure: type of comedications used during the 12-months study period
timeFrame: Between DAY 0 (D0) and Month 12 (M12)
Other outcomes:
Locations:
city: Fort-de-france
country: France
facility: Hopital Zobda Quitman
state: Martinique
city: Bordeaux
country: France
facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
city: Caen
country: France
facility: Hôpital Côte de Nacre - Service des Maladies Infectieuses
city: Corbeil-Essonnes
country: France
facility: Centre hospitalier Sud Francilien
city: Créteil
country: France
facility: Hôpital Henri Mondor - Service d'Immunologie Clinique
city: Dijon
country: France
facility: Hopital Francois Mitterrand
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Marseille
country: France
facility: Hopital Sainte-Marguerite
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
city: Nice
country: France
facility: L'ARCHET
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Tenon
city: Suresnes
country: France
facility: Hopital Foch
city: Tourcoing
country: France
facility: Hopital Gustave Dron
city: Tours
country: France
facility: Hopital Bretonneau
Study officials:
References: