MedTrace Logo

Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

NCT00822315 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2013-07-17

No results posted yet for this study

Summary

Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.

Conditions

Interventions

DRUG

efavirenz

tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg

DRUG

raltegravir

tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg

DRUG

raltegravir

tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg

Sponsors & Collaborators

Principal Investigators

  • Beatriz Grinsztejn, MD · Fiocruz, Rio de Janiero, Brazil

  • Jean-Michel Molina, MD · Hôpital Saint-Louis, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • Brazil
  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00822315 on ClinicalTrials.gov