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

NCT ID: NCT01114425

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-01
• Study Completion Date: 2012-12-01

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.

Conditions

HIV Infections

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

raltegravir (Isentress)

raltegravir (Isentress) 400 mg bid

Intervention Type: DRUG

Truvada®

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

NETWORK

Sponsor Role: lead

Responsible Party

GERES

Principal Investigators

Christian RABAUD, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Locations

GERES

Paris, , France

Countries

France

Other Identifiers

382426005_1

Identifier Type: -

Identifier Source: org_study_id