HIV Infections Clinical Trial
Official title:
The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania
In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.
The primary objectives of this pilot study in 30 patients are:
1. To determine the effect of rifampin-containing tuberculostatic treatment on the
pharmacokinetic profile of emtricitabine+tenofovir+efavirenz, when co-formulated in one
tablet, in HIV-infected patients with smear-positive pulmonary tuberculosis in
Tanzania.
2. To determine the effect of the emtricitabine+tenofovir+efavirenz regimen on the
pharmacokinetics of tuberculostatics in the same population.
The secondary objectives are:
1. To determine the safety of co-administration of emtricitabine+tenofovir+efavirenz with
treatment for smear-positive pulmonary tuberculosis.
2. To determine the short-term (24 weeks) virological efficacy on HIV of an
emtricitabine+tenofovir+efavirenz regimen in patients with smear-positive pulmonary
tuberculosis.
3. To determine the short-term bacteriological efficacy on smear-positive tuberculosis of
the co-administration of a standard regimen for tuberculosis and an
emtricitabine+tenofovir+efavirenz regimen.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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