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

Hiv Clinical Trial

— AES ODEFSEY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451032
• Other study ID #: RC17_0485
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: August 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Non Interventional Study
Non Interventional Study

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	La Roche sur Yon Hospital	La Roche-sur-Yon
France	Laval Hospital	Laval
France	Le Mans Hospital	Le Mans
France	Nantes University Hospital	Nantes
France	Saint-Nazaire Hospital	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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