Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis

Phase 3

Completed

• Conditions: HIV Risk
• Interventions: Drug: Genvoya

• Registration Number: NCT02998320
• Lead Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Brief Summary

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

Detailed Description

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.

Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2017-03-10
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• an age above 18 years
• consultation within 48 hours following a risk of HIV transmission (blood or sexual contact)
• indication for HIV post-exposure prophylaxis (according to French guidelines)
• person able to understand the nature of the study
• person who signed his consent form to participate in the study

Exclusion Criteria

• person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
• contraindications to the prescription of Genvoy
• other medical contraindications
• person infected by hepatitis B virus
• pregnant or lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genvoya	Genvoya	Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days

Primary Outcome Measures

Name	Time	Method
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks	Day 28

Trial Locations

Locations (16)

Hôpital Saint-André; 🇫🇷 Bordeaux, France

CHU Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

Hôpital Manchester; 🇫🇷 Charleville-Mézières, France

CHU Dijon; 🇫🇷 Dijon, France

Hôpital Croix Rousse; 🇫🇷 Lyon, France

Hôpital Tenon; 🇫🇷 Paris, France

CHU Bichat; 🇫🇷 Paris, France

Hôpital Saint-Antoine; 🇫🇷 Paris, France

GH Pitié Salpetriere; 🇫🇷 Paris, France

CHU de Reims; 🇫🇷 Reims, France

CHU; 🇫🇷 Rennes, France

Hôpitaux Universitaires; 🇫🇷 Strasbourg, France

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital de Tourcoing; 🇫🇷 Tourcoing, France

Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHR de Metz; 🇫🇷 Metz, France