NCT03858478

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV Seropositivity

Interventions

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

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-03-31
• Completion: 2021-12-31
• First posted: 2019-02-28
• Last updated: 2020-01-09

Locations

17 sites across 1 country: France