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
  Purpose

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.


Condition Intervention Phase
Tuberculosis
HIV Infections
Drug: Emtricitabine/tenofovir/efavirenz
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by African Poverty Related Infection Oriented Research Initiative:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Intervention Details:
    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
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474435

Contacts
Contact: Gibson Kibiki, MMed, PhD +255 754 572767 gkibiki@gmail.com
Contact: Jossy van den Boogaard, MD +255 787 148431 jossyvandenboogaard@gmail.com

Locations
Tanzania
Kibong'oto National Tuberculosis Hospital Recruiting
Moshi, Kilimanjaro Region, Tanzania, P.O. Box 12
Contact: Liberate Mleoh, MD    027 2756194    lmleoh@yahoo.com   
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         
Sponsors and Collaborators
African Poverty Related Infection Oriented Research Initiative
Radboud University
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
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
  More Information

Publications:

Responsible Party: Martin Boeree, University Lungcentre Dekkerswald, Groesbeek, the Netherlands
ClinicalTrials.gov Identifier: NCT00474435     History of Changes
Other Study ID Numbers: UMCN-AKF 04.03
Study First Received: May 16, 2007
Last Updated: December 16, 2010
Health Authority: Tanzania: Food & Drug Administration

Keywords provided by African Poverty Related Infection Oriented Research Initiative:
Tuberculosis
HIV
Coinfection
Pharmacokinetics
Emtricitabine
Tenofovir
Rifampin
Efavirenz
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 01, 2014