Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis (PETE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by African Poverty Related Infection Oriented Research Initiative.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Radboud University
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by:
African Poverty Related Infection Oriented Research Initiative
ClinicalTrials.gov Identifier:
NCT00474435
First received: May 16, 2007
Last updated: December 16, 2010
Last verified: December 2008

May 16, 2007
December 16, 2010
November 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Pharmacokinetic parameters of emtricitabine, tenofovir and efavirenz [ Time Frame: Two 24 h PK curves (week 8 and 28) ]
  • Pharmacokinetic parameters of the tuberculostatic agents [ Time Frame: PK samples at 2h and 6 h postdose (week 2 and 8) ]
Complete list of historical versions of study NCT00474435 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis
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.
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tuberculosis
  • HIV Infections
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A smear-positive pulmonary tuberculosis, based on positive smear of at least two sputum samples with Ziehl-Neelsen (ZN) staining.
  • HIV-infected as documented by positive HIV antibody test.
  • Subject is at least 18 years of age at the day of the first dosing of study medication.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • CD4 cell count > 50 copies/mm3.
  • Karnofsky score > 40.
  • Willing and able to regularly attend the Kibung'oto National Tuberculosis Hospital (KNTH) clinic.

Exclusion Criteria:

  • History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
  • Previously treated for HIV infection with antiretroviral agents.
  • Pregnant or breastfeeding.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • A history of severe psychiatric disease such as psychosis, schizophrenia, etc.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Abnormal serum transaminases or creatinine, determined as levels being > 5 times upper limit of normal.
  • Active hepatobiliary or hepatic disease (Non B Chronic Hepatitis B/C co-infection is allowed).
  • CD4 cell count > 350 cells/mm3.
Both
18 Years to 65 Years
No
Contact: Gibson Kibiki, MMed, PhD +255 754 572767 gkibiki@gmail.com
Contact: Jossy van den Boogaard, MD +255 787 148431 jossyvandenboogaard@gmail.com
Tanzania
 
NCT00474435
UMCN-AKF 04.03
Yes
Martin Boeree, University Lungcentre Dekkerswald, Groesbeek, the Netherlands
African Poverty Related Infection Oriented Research Initiative
  • Radboud University
  • Kilimanjaro Christian Medical Centre, Tanzania
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
African Poverty Related Infection Oriented Research Initiative
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP