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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114425
• Other study ID #: 382426005_1
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2010
• Last updated: February 22, 2017
• Start date: November 1, 2010
• Est. completion date: December 1, 2012

Study information

• Verified date: February 2017
• Source: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 1, 2012
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• raltegravir (Isentress)
raltegravir (Isentress) 400 mg bid
• Truvada®

Locations

Country	Name	City	State
France	GERES	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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