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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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* 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

Conditions

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HIV Seropositivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study, single arm, multicentric, national

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biktarvy arm

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

Group Type EXPERIMENTAL

Biktarvy arm

Intervention Type DRUG

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

Interventions

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Biktarvy arm

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No