Clinical Trials

MainTitle

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

This study has been enrolling by invitation
Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Collaborator
Gilead Sciences

Information provided by (Responsible Party)
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
ClinicalTrials.gov Identifier
NCT02998320

First received: December 14, 2016
Last updated: February 13, 2018
Last Verified: February 2018
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Risk

Drug : Genvoya
Phase 3

Study Type: Interventional
Study Design: 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)

Further study details as provided by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux:

Primary Outcome Measures

  • Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks [ Time Frame: Day 28 ]

Estimated Enrollment: 100
Study Start Date: March 10, 2017
Estimated Study Completion Date: July 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02998320

Locations

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

Principal Investigator: David Rey Hôpitaux Universitaires de Strasbourg
More Information

More Information


Responsible Party: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux  
ClinicalTrials.gov Identifier: NCT02998320   History of Changes  
Other Study ID Numbers: GEFR1044015  
Study First Received: December 14, 2016  
Last Updated: February 13, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Emtricitabine
Cobicistat

ClinicalTrials.gov processed this data on September 21, 2018
This information is provided by ClinicalTrials.gov.