Clinical trial NCT02998320: Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Risk
Lead sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Sponsor class: NETWORK
Collaborators: name: Gilead Sciences
First posted: 2016-12-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Charleville-Mézières
country: France
facility: Hôpital Manchester
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: Hôpital Croix Rousse
city: Metz
country: France
facility: CHR de Metz
city: Paris
country: France
facility: CHU Bichat
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: GH Pitié Salpetriere
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU
city: Strasbourg
country: France
facility: Hôpitaux Universitaires
city: Suresnes
country: France
facility: Hôpital Foch
city: Tourcoing
country: France
facility: Hôpital de Tourcoing
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: David Rey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.