Trial | NCT01114425  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    149
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 Started
Nov 01
2010
Primary Completion
Aug 01
2012
Study Completion
Dec 01
2012
Last Update
Feb 23
2017

Drug raltegravir (Isentress)

raltegravir (Isentress) 400 mg bid

Drug Truvada®

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
No Results Posted