Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Nantes University Hospital


Information provided by (Responsible Party)
Nantes University Hospital
ClinicalTrials.gov Identifier
NCT03451032

First received: February 19, 2018
Last updated: August 23, 2019
Last Verified: August 2019
History of Changes
Purpose

Purpose

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.

At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.

Condition Intervention
Hiv

Other : Non Interventional Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures

  • Proportion of participants who stopped the 28-day course of TAF/FTC/RPV [ Time Frame: At 6 weeks ]
    : Phone call to all participants to check on their adherence and to collect information about possible side effects
Secondary Outcome Measures:
  • Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV [ Time Frame: At 6 weeks ]
    Phone call to all participants to collect information about possible side effects.

Enrollment: 150
Study Start Date: March 15, 2018
Study Completion Date: March 15, 2019
Primary Completion Date: March 15, 2019 (Final data collection date for primary outcome measure)

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 according to national guidelines. They have to start this post-exposure prophylaxis within 48 hours after the HIV exposure.
At inclusion, participants give their written consent to have their data recorded in an electronic medical record Nadis® and their oral consent after reading the study information letter. A blood test is prescribed to examine biological variables (HIV, HBV, HCV serologies, TPHA VDRL, ALT/AST, hemogram and serum creatinine). Characteristics of participants and context of the risk are collected in the electronic medical record Nadis®. A blood test is prescribed at W2, W6 and W12 to evaluate tolerability and efficacy of the treatment.
At W6, all participants are contacted by phone call to evaluate completeness and tolerability of the TAF/FTC/RPV regimen. They are reminded to have a blood test done at W6 and W12.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Persons included in the study are adults who seek care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area after a potential sexual or blood HIV exposure with an indication of HIV post-exposure prophylaxis according to the French guidelines.

Criteria

Inclusion Criteria:

  • 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 Criteria:
  • 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

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: NCT03451032

Locations

France
Angers University Hospital
Angers, France, 49000
La Roche sur Yon Hospital
La Roche-sur-Yon, France, 85000
Laval Hospital
Laval, France, 53000
Le Mans Hospital
Le Mans, France, 72000
Nantes University Hospital
Nantes, France, 44093
Saint-Nazaire Hospital
Saint-Nazaire, France, 44600

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Bénédicte BONNET, Dr Nantes University Hospital
More Information

More Information


Responsible Party: Nantes University Hospital  
ClinicalTrials.gov Identifier: NCT03451032   History of Changes  
Other Study ID Numbers: RC17_0485  
Study First Received: February 19, 2018  
Last Updated: August 23, 2019  
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  

Keywords provided by Nantes University Hospital:

HIV exposition treatment
sexual risk
blood risk

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.