Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis (PETE)
|ClinicalTrials.gov Identifier: NCT00474435|
Recruitment Status : Unknown
Verified December 2008 by African Poverty Related Infection Oriented Research Initiative.
Recruitment status was: Recruiting
First Posted : May 17, 2007
Last Update Posted : December 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV Infections||Drug: Emtricitabine/tenofovir/efavirenz||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
- emtricitabine 200 mg
- tenofovir DF 300 mg
- efavirenz 600 mg
Co-formulated in one tablet (taken once daily by oral administration):
- Pharmacokinetic 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474435
|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|