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
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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) |
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 |
Study Start Date : | November 2008 |
Estimated Primary Completion Date : | December 2009 |
Estimated Study Completion Date : | December 2009 |
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Drug: Emtricitabine/tenofovir/efavirenz
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 572767 | gkibiki@gmail.com | |
Contact: Jossy van den Boogaard, MD | +255 787 148431 | jossyvandenboogaard@gmail.com |
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 |
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 |
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 |
First Posted: | May 17, 2007 Key Record Dates |
Last Update Posted: | December 17, 2010 |
Last Verified: | December 2008 |
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 Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Tenofovir |
Emtricitabine Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers |