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)

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: Non Interventional Study

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Bénédicte BONNET, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: sexual risk; HIV exposition treatment; blood risk
• Other Study ID Numbers: RC17_0485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No