NCT00822315

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

Phase II Open-label Randomized Multicenter Trial to Compare the Efficacy and Safety of Two Different Doses of Raltegravir and Efavirenz, All in Combination With Tenofovir and Lamivudine, in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-11-01
• Completion: 2012-05-01
• First posted: 2009-01-14
• Last updated: 2013-07-17

Locations

9 sites across 2 countries: Brazil, France