drugset / Trial / NCT00651066

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam

NCT00651066

RandomizedCrossoverOpen-labelTreatment

Summary

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

Timeline

Start
2010-06
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lopinavir Other / unclassified 800 mg
Subject Rifabutin Small molecule 150 mg
Subject Ritonavir Other / unclassified 200 mg
Background EMT Unknown
Background INH Unknown
Background Lamivudine Other / unclassified 300 mg
Background PZA Unknown
Background Stavudine Other / unclassified 60 mg