Overview

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

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators:
Gilead Sciences
Merck Sharp & Dohme Corp.
Treatments:
Efavirenz
Lamivudine
Raltegravir Potassium
Rifampin
Tenofovir