Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis (PETE)
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|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|
- Drug: Emtricitabine/tenofovir/efavirenz
Co-formulated in one tablet (taken once daily by oral administration):
- emtricitabine 200 mg
- tenofovir DF 300 mg
- efavirenz 600 mg
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|