Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis
NCT ID: NCT00474435
Last Updated: 2010-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2008-11-30
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Emtricitabine/tenofovir/efavirenz
Co-formulated in one tablet (taken once daily by oral administration):
* emtricitabine 200 mg
* tenofovir DF 300 mg
* efavirenz 600 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Kilimanjaro Christian Medical Centre, Tanzania
OTHER
African Poverty Related Infection Oriented Research Initiative
OTHER
Responsible Party
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University Lungcentre Dekkerswald, Groesbeek, the Netherlands
Principal Investigators
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Martin Boeree, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Lungcentre Dekkerswald, Groesbeek / University Medical Centre Nijmegen, the Netherlands
David Burger, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Nijmegen, the Netherlands
Gibson Kibiki, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
Kilimanjaro Christian Medical Centre,Moshi,Tanzania
Locations
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Kibong'oto National Tuberculosis Hospital
Moshi, Kilimanjaro, Tanzania
Countries
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Central Contacts
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Facility Contacts
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Liberate Mleoh, MD
Role: primary
References
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Bowen EF, Rice PS, Cooke NT, Whitfield RJ, Rayner CF. HIV seroprevalence by anonymous testing in patients with Mycobacterium tuberculosis and in tuberculosis contacts. Lancet. 2000 Oct 28;356(9240):1488-9. doi: 10.1016/S0140-6736(00)02876-2.
Msamanga GI, Fawzi WW. The double burden of HIV infection and tuberculosis in sub-Saharan Africa. N Engl J Med. 1997 Sep 18;337(12):849-51. doi: 10.1056/NEJM199709183371210. No abstract available.
Dean GL, Edwards SG, Ives NJ, Matthews G, Fox EF, Navaratne L, Fisher M, Taylor GP, Miller R, Taylor CB, de Ruiter A, Pozniak AL. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002 Jan 4;16(1):75-83. doi: 10.1097/00002030-200201040-00010.
Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002.
Finch CK, Chrisman CR, Baciewicz AM, Self TH. Rifampin and rifabutin drug interactions: an update. Arch Intern Med. 2002 May 13;162(9):985-92. doi: 10.1001/archinte.162.9.985.
Lopez-Cortes LF, Ruiz-Valderas R, Viciana P, Alarcon-Gonzalez A, Gomez-Mateos J, Leon-Jimenez E, Sarasanacenta M, Lopez-Pua Y, Pachon J. Pharmacokinetic interactions between efavirenz and rifampicin in HIV-infected patients with tuberculosis. Clin Pharmacokinet. 2002;41(9):681-90. doi: 10.2165/00003088-200241090-00004.
Burger DM, Meenhorst PL, Koks CH, Beijnen JH. Pharmacokinetic interaction between rifampin and zidovudine. Antimicrob Agents Chemother. 1993 Jul;37(7):1426-31. doi: 10.1128/AAC.37.7.1426.
Gallicano KD, Sahai J, Shukla VK, Seguin I, Pakuts A, Kwok D, Foster BC, Cameron DW. Induction of zidovudine glucuronidation and amination pathways by rifampicin in HIV-infected patients. Br J Clin Pharmacol. 1999 Aug;48(2):168-79. doi: 10.1046/j.1365-2125.1999.00987.x.
Friedland G, Abdool Karim S, Abdool Karim Q, Lalloo U, Jack C, Gandhi N, El Sadr W. Utility of tuberculosis directly observed therapy programs as sites for access to and provision of antiretroviral therapy in resource-limited countries. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S421-8. doi: 10.1086/421407.
Droste JA, Aarnoutse RE, Koopmans PP, Hekster YA, Burger DM. Evaluation of antiretroviral drug measurements by an interlaboratory quality control program. J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):287-91. doi: 10.1097/00126334-200303010-00007.
Holland DT, DiFrancesco R, Stone J, Hamzeh F, Connor JD, Morse GD; Adult and Pediatric AIDS Clinical Trials Group Pharmacology Laboratory Committees, Pediatric AIDS Clinical Trials Group. Quality assurance program for clinical measurement of antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and adult pharmacology laboratories. Antimicrob Agents Chemother. 2004 Mar;48(3):824-31. doi: 10.1128/AAC.48.3.824-831.2004.
Marzolini C, Telenti A, Decosterd LA, Greub G, Biollaz J, Buclin T. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS. 2001 Jan 5;15(1):71-5. doi: 10.1097/00002030-200101050-00011.
Other Identifiers
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UMCN-AKF 04.03
Identifier Type: -
Identifier Source: org_study_id