Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998320
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
HIV Risk Drug: Genvoya Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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
Drug: Genvoya
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
Other Name: (E/C/F/TAF) ATC Code: J05AR18




Primary Outcome Measures :
  1. Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks [ Time Frame: Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998320


Locations
Layout table for location information
France
Hôpital Jean Minjoz
Besançon, France, 25030
Hôpital Saint-André
Bordeaux, France, 33075
CHU Ambroise Paré
Boulogne-Billancourt, France, 92100
Hôpital Manchester
Charleville-Mézières, France, 08011
CHU Dijon
Dijon, France, 77908
Hôpital Croix Rousse
Lyon, France, 69317
CHR de Metz
Metz, France, 57050
CHU Bichat
Paris, France, 75018
Hôpital Tenon
Paris, France, 75020
Hôpital Saint-Antoine
Paris, France, 75571
GH Pitié Salpetriere
Paris, France, 75651
CHU de Reims
Reims, France, 51092
CHU
Rennes, France, 35033
Hôpitaux Universitaires
Strasbourg, France, 67091
Hôpital Foch
Suresnes, France, 92150
Hôpital de Tourcoing
Tourcoing, France, 59208
Sponsors and Collaborators
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Gilead Sciences
Investigators
Layout table for investigator information
Principal Investigator: David Rey Hôpitaux Universitaires de Strasbourg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
ClinicalTrials.gov Identifier: NCT02998320    
Other Study ID Numbers: GEFR1044015
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Genvoya
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents