Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
Recruitment status was Not yet recruiting
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.
|Study Design:||Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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. [ Time Frame: one year ] [ Designated as safety issue: No ]
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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Drug: raltegravir (Isentress)
|GERES||Not yet recruiting|
|Contact: RABAUD email@example.com|
|Principal Investigator:||Christian RABAUD, MD., PhD.||Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux|