Clinical trial NCT03451032: Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Keywords: HIV exposition treatment
sexual risk
blood risk
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants who stopped the 28-day course of TAF/FTC/RPV
timeFrame: At 6 weeks
Secondary outcomes:
measure: Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: La Roche-sur-Yon
country: France
facility: La Roche sur Yon Hospital
city: Laval
country: France
facility: Laval Hospital
city: Le Mans
country: France
facility: Le Mans Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
Study officials:
affiliation: Nantes University Hospital
name: Bénédicte BONNET, Dr
role: PRINCIPAL_INVESTIGATOR
References: