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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Co-formulated in one tablet (taken once daily by oral administration): * emtricitabine 200 mg * tenofovir DF 300 mg * efavirenz 600 mg
Kibong'oto National Tuberculosis Hospital
Moshi, Kilimanjaro, Tanzania
RECRUITINGPharmacokinetic parameters of emtricitabine, tenofovir and efavirenz
Time frame: Two 24 hour pharmacokinetic (PK) curves (week 8 and 28)
Pharmacokinetic parameters of the tuberculostatic agents
Time frame: Pharmacokinetic (PK) samples at 2 hours and 6 hours postdose (week 2 and 8)
Biochemistry and haematology samples for safety
Time frame: Samples at screening, baseline, week 2, 4, 6, 8, 12, 16, 24, 28
Questioning about occurrence of adverse events
Time frame: At baseline, week 2, 4, 6, 8, 12, 16, 24, 28
CD4 count and HIV-1 RNA
Time frame: At screening, week 4, week 16 and week 28
Sputum staining and culture
Time frame: At screening, week 4, 8, and 28
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