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

Completed

• Conditions: Hiv

• Registration Number: NCT03451032
• Lead Sponsor: Nantes University Hospital

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Study Start: 2018-03-15
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants who stopped the 28-day course of TAF/FTC/RPV	At 6 weeks	: Phone call to all participants to check on their adherence and to collect information about possible side effects

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV	At 6 weeks	Phone call to all participants to collect information about possible side effects.

Trial Locations

Locations (6)

Angers University Hospital; 🇫🇷 Angers, France

La Roche sur Yon Hospital; 🇫🇷 La Roche-sur-Yon, France

Nantes University Hospital; 🇫🇷 Nantes, France

Laval Hospital; 🇫🇷 Laval, France

Le Mans Hospital; 🇫🇷 Le Mans, France

Saint-Nazaire Hospital; 🇫🇷 Saint-Nazaire, France