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

HIV Risk Clinical Trial

Official title:

Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998320
• Other study ID #: GEFR1044015
• Status: Completed
• Phase: Phase 3
• Start date: March 10, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2019
• Source: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Risk

Intervention

Drug:
• Genvoya
Oral use (one tablet each day); 150/150/200/10 mg; 28 days

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz	Besançon
France	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	CHR de Metz	Metz
France	CHU Bichat	Paris
France	GH Pitié Salpetriere	Paris
France	Hôpital Saint-Antoine	Paris
France	Hôpital Tenon	Paris
France	CHU de Reims	Reims
France	CHU	Rennes
France	Hôpitaux Universitaires	Strasbourg
France	Hôpital Foch	Suresnes
France	Hôpital de Tourcoing	Tourcoing

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux	Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks		Day 28