Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
1 other identifier
interventional
101
1 country
16
Brief Summary
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFebruary 15, 2019
February 1, 2019
1.3 years
December 14, 2016
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
Day 28
Study Arms (1)
Genvoya
EXPERIMENTALGenvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
Interventions
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Hôpital Jean Minjoz
Besançon, 25030, France
Hôpital Saint-André
Bordeaux, 33075, France
CHU Ambroise Paré
Boulogne-Billancourt, 92100, France
Hôpital Manchester
Charleville-Mézières, 08011, France
CHU Dijon
Dijon, 77908, France
Hôpital Croix Rousse
Lyon, 69317, France
CHR de Metz
Metz, 57050, France
CHU Bichat
Paris, 75018, France
Hôpital Tenon
Paris, 75020, France
Hôpital Saint-Antoine
Paris, 75571, France
GH Pitié Salpetriere
Paris, 75651, France
CHU de Reims
Reims, 51092, France
CHU
Rennes, 35033, France
Hôpitaux Universitaires
Strasbourg, 67091, France
Hôpital Foch
Suresnes, 92150, France
Hôpital de Tourcoing
Tourcoing, 59208, France
Related Publications (1)
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.
PMID: 31804669DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Rey
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2016
First Posted
December 20, 2016
Study Start
March 10, 2017
Primary Completion
June 30, 2018
Study Completion
September 30, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share