HIV Infections Clinical Trial
Official title:
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in the Treatment of Tuberculosis Patient With HIV Infection in Vietnam : A Phase II Trial
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.
Patients will be offered to participated in the study when they start TB treatment. All the enrolled patients will immediately be switched to rifabutin and randomized, to one of the RBT doses that will be then adapted to the allocated RBT regimen according to a cross over scheme. Three full pharmacokinetics profile will be performed at different time point : before initiation of ARV, after three weeks of the first RBT dosage and after three weeks of the secondRBT dosage. Patients will then be referred to the national program for further treatment. A follow-up visit will be planned at the end of the antiTB treatment. ;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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