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
1 other identifier
observational
150
1 country
6
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedStudy Start
First participant enrolled
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedAugust 28, 2019
August 1, 2019
1 year
February 19, 2018
August 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants who stopped the 28-day course of TAF/FTC/RPV
: Phone call to all participants to check on their adherence and to collect information about possible side effects
At 6 weeks
Secondary Outcomes (1)
Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV
At 6 weeks
Interventions
Non Interventional Study
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Angers University Hospital
Angers, 49000, France
La Roche sur Yon Hospital
La Roche-sur-Yon, 85000, France
Laval Hospital
Laval, 53000, France
Le Mans Hospital
Le Mans, 72000, France
Nantes University Hospital
Nantes, 44093, France
Saint-Nazaire Hospital
Saint-Nazaire, 44600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bénédicte BONNET, Dr
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
March 1, 2018
Study Start
March 15, 2018
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share