Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03451032
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV
Sponsor:
Nantes University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AES ODEFSEY
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: