Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

Study Overview
=================
Brief Summary
-----------------
The objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, Truvada® [0-0-1] + Isentress® 400 mg tablets [1-0-1], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of HIV infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.

Official Title
-----------------
Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: raltegravir (Isentress)
* Drug: Truvada®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria age 18 years or over consultation immediately following exposure to the risk of transmission of HIV infection (less than 48 hours, except in the case of rape when this period may be increased to a maximum of 120 hours) person capable of understanding the principle of the study and giving his/her informed consent Exclusion criteria subjects recently exposed to a risk of transmission of HIV infection in which the source patient is known to be infected with HIV and treated, and whose therapeutic history justifies the introduction of PET other than that proposed in this study subjects with a contraindication to the prescription of Truvada® and/or Isentress® (renal impairment, allergy, etc.) subjects previously treated with phenytoin, phenobarbital and rifampicin, since combination with raltegravir is contraindicated subjects known to be infected with hepatitis B virus, whether or not treated with lamivudine subjects refusing to take part in the study pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raltegravir (Isentress)|raltegravir (Isentress) 400 mg bid|
|Drug: Truvada®|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the nature and incidence of drug intolerance and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals. | Proportion of patients who stop the post-exposure treatment before the planned 28 days, owing to adverse reaction(s). Proportion of patients reporting a post-exposure treatment-related side effect before the end of the treatment. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tolerability of post exposure to HIV infection prophylaxis