Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
February 13, 2019 updated by: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
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)
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks
Study Overview
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 Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Besançon, France, 25030
- Hôpital Jean Minjoz
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Bordeaux, France, 33075
- Hôpital Saint-André
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Boulogne-Billancourt, France, 92100
- CHU Ambroise Pare
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Charleville-Mézières, France, 08011
- Hôpital Manchester
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Dijon, France, 77908
- CHU Dijon
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Lyon, France, 69317
- Hopital croix rousse
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Metz, France, 57050
- CHR de Metz
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Paris, France, 75020
- Hôpital Tenon
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Paris, France, 75571
- Hopital Saint-Antoine
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Paris, France, 75018
- CHU Bichat
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Paris, France, 75651
- GH Pitié Salpêtrière
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Reims, France, 51092
- CHU de Reims
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Rennes, France, 35033
- CHU
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Strasbourg, France, 67091
- Hôpitaux Universitaires
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Suresnes, France, 92150
- Hôpital Foch
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Tourcoing, France, 59208
- Hôpital de Tourcoing
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Genvoya
Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
|
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David REY, Hôpitaux universitaires de Strasbourg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2017
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
December 19, 2016
First Posted (Estimate)
December 20, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEFR1044015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.