Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis (PETE)
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania|
- Pharmacokinetic parameters of emtricitabine, tenofovir and efavirenz [ Time Frame: Two 24 hour pharmacokinetic (PK) curves (week 8 and 28) ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of the tuberculostatic agents [ Time Frame: Pharmacokinetic (PK) samples at 2 hours and 6 hours postdose (week 2 and 8) ] [ Designated as safety issue: No ]
- Biochemistry and haematology samples for safety [ Time Frame: Samples at screening, baseline, week 2, 4, 6, 8, 12, 16, 24, 28 ] [ Designated as safety issue: Yes ]
- Questioning about occurrence of adverse events [ Time Frame: At baseline, week 2, 4, 6, 8, 12, 16, 24, 28 ] [ Designated as safety issue: Yes ]
- CD4 count and HIV-1 RNA [ Time Frame: At screening, week 4, week 16 and week 28 ] [ Designated as safety issue: Yes ]
- Sputum staining and culture [ Time Frame: At screening, week 4, 8, and 28 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- emtricitabine 200 mg
- tenofovir DF 300 mg
- efavirenz 600 mg
Co-formulated in one tablet (taken once daily by oral administration):
The primary objectives of this pilot study in 30 patients are:
- 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.
- To determine the effect of the emtricitabine+tenofovir+efavirenz regimen on the pharmacokinetics of tuberculostatics in the same population.
The secondary objectives are:
- To determine the safety of co-administration of emtricitabine+tenofovir+efavirenz with treatment for smear-positive pulmonary tuberculosis.
- To determine the short-term (24 weeks) virological efficacy on HIV of an emtricitabine+tenofovir+efavirenz regimen in patients with smear-positive pulmonary tuberculosis.
- 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.
|Contact: Gibson Kibiki, MMed, PhD||+255 754 firstname.lastname@example.org|
|Contact: Jossy van den Boogaard, MD||+255 787 email@example.com|
|Kibong'oto National Tuberculosis Hospital||Recruiting|
|Moshi, Kilimanjaro Region, Tanzania, P.O. Box 12|
|Contact: Liberate Mleoh, MD 027 2756194 firstname.lastname@example.org|
|Principal Investigator: Gibson Kibiki, MMed, PhD|
|Sub-Investigator: Elton Kisanga, B-Pharm, PhD|
|Sub-Investigator: Liberate Mleoh, MD|
|Sub-Investigator: Jossy van den Boogaard, MD|
|Sub-Investigator: Hadija Semvua, B-Pharm, MPH|
|Sub-Investigator: Charles Mtabho, MD, MPH|
|Principal Investigator:||Martin Boeree, MD, PhD||University Lungcentre Dekkerswald, Groesbeek / University Medical Centre Nijmegen, the Netherlands|
|Principal Investigator:||David Burger, PharmD, PhD||University Medical Centre Nijmegen, the Netherlands|
|Principal Investigator:||Gibson Kibiki, MMed, PhD||Kilimanjaro Christian Medical Centre, Moshi, Tanzania|