Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis