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

NCT01114425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2017-02-23

No results posted yet for this study

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

DRUG

raltegravir (Isentress)

raltegravir (Isentress) 400 mg bid

DRUG

Truvada®

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

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

    lead NETWORK

Principal Investigators

  • Christian RABAUD, MD., PhD. · Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-01
Primary Completion
2012-08-01
Completion
2012-12-01

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114425 on ClinicalTrials.gov