NCT01114425

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	raltegravir (Isentress)	raltegravir (Isentress) 400 mg bid
DRUG	Truvada®

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2010-05-03
• Last updated: 2017-02-23

Locations

1 site across 1 country: France