Status:

COMPLETED

Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

Lead Sponsor:

Nantes University Hospital

Conditions:

Hiv

Eligibility:

MALE

18+ years

Brief Summary

Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV. ...

Detailed Description

At baseline, participants seek care in one of the centers of " Pays de la Loire " area after a potential HIV exposure. They receive TAF/FTC/RPV, one pill taken with food once daily for 28 days accordi...

Eligibility Criteria

Inclusion

  • Subject seeking care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area (CHU Nantes, CHU Angers, CHD La Roche sur Yon, CH Le Mans, CH Saint Nazaire, CH Laval) after a potential sexual or non-sexual HIV exposure
  • Adult ≥18 years old
  • Oral informed consent
  • Written informed consent to have their data recorded in an electronic medical record ("Nadis" software).
  • Indication of HIV post-exposure prophylaxis according to the French guidelines

Exclusion

  • Subject not willing or refusing to participate
  • Subject on legal protection
  • HIV positive status
  • Pregnancy or breastfeeding
  • Already treated by pre exposure prophylaxis
  • Already included in the study

Key Trial Info

Start Date :

March 15 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 15 2019

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03451032

Start Date

March 15 2018

End Date

March 15 2019

Last Update

August 28 2019

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Angers University Hospital

Angers, France, 49000

2

La Roche sur Yon Hospital

La Roche-sur-Yon, France, 85000

3

Laval Hospital

Laval, France, 53000

4

Le Mans Hospital

Le Mans, France, 72000

Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV | DecenTrialz