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)
Nantes University Hospital
Information provided by (Responsible Party)
Nantes University Hospital
First received: February 19, 2018
Last updated: August 23, 2019
Last Verified: August 2019
History of Changes
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.
Other : Non Interventional Study
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
- 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.
|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)|
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Study PopulationPersons 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.
- 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
- 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 LocationsChoosing 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 Show More
|Angers University Hospital|
|Angers, France, 49000|
|La Roche sur Yon Hospital|
|La Roche-sur-Yon, France, 85000|
|Laval, France, 53000|
|Le Mans Hospital|
|Le Mans, France, 72000|
|Nantes University Hospital|
|Nantes, France, 44093|
|Saint-Nazaire, France, 44600|
Sponsors and CollaboratorsNantes University Hospital
|Principal Investigator:||Bénédicte BONNET, Dr||Nantes University Hospital|
|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
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.