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Sponsors and Collaborators: |
African Poverty Related Infection Oriented Research Initiative Radboud University Kilimanjaro Christian Medical Centre, Tanzania |
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Information provided by: | African Poverty Related Infection Oriented Research Initiative |
ClinicalTrials.gov Identifier: | NCT00474435 |
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 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 |
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Tuberculosis HIV Infections |
Drug: Emtricitabine/tenofovir/efavirenz |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Pharmacokinetics of co-Formulated Emtricitabine/Tenofovir/Efavirenz in HIV-Infected Patients With Smear-Positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania |
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) |
Co-formulated in one tablet (taken once daily by oral administration):
The primary objectives of this pilot study in 30 patients are:
The secondary objectives are:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gibson Kibiki, MMed, PhD | +255 754 572767 | gkibiki@gmail.com |
Contact: Jossy van den Boogaard, MD | +255 787 148431 | jossyvandenboogaard@gmail.com |
Tanzania, Kilimanjaro Region | |
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 |
Responsible Party: | Univiersity Lungcentre Dekkerswald, Groesbeek, the Netherlands ( Martin Boeree ) |
Study ID Numbers: | UMCN-AKF 04.03 |
Study First Received: | May 16, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00474435 History of Changes |
Health Authority: | Tanzania: Food & Drug Administration |
Tuberculosis HIV Coinfection Pharmacokinetics Emtricitabine |
Tenofovir Rifampin Efavirenz Treatment Naive |
Bacterial Infections Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Rifampin Gram-Positive Bacterial Infections |
Anti-Retroviral Agents Emtricitabine HIV Infections Tuberculosis, Pulmonary Sexually Transmitted Diseases Tenofovir Mycobacterium Infections Tuberculosis Retroviridae Infections Tenofovir disoproxil |
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Gram-Positive Bacterial Infections Anti-Retroviral Agents Emtricitabine Therapeutic Uses Tenofovir Tuberculosis Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Tenofovir disoproxil Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |