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Sponsors and Collaborators: |
Makerere University Health Research Board, Ireland |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00620438 |
There are increasing numbers of HIV-infected patients in sub-Saharan Africa receiving antiretroviral drugs and/or rifampicin based antituberculous therapy. HIV infected patients are at an increased risk of contracting malaria. Increasing resistance to anti-malarials such as chloroquine, amodiaquine, fansidar, sulphadoxine-pyrimethamine in East and West Africa has led the WHO to recommend artemether-lumefantrine (Coartem®- Novartis) as first line therapy for malaria for adults and children. As early as 2004, fourteen countries in sub-Saharan Africa had adopted this guideline as national policy.
There are no data on the interaction between Coartem® and any of the antiretroviral agents. Both components of Coartem® are substrates for the 3A4 isoform of cytochrome P450. Despite the lack of data, antiretroviral drugs and/or antituberculous drugs in addition to Coartem® are of necessity co-prescribed daily in the African setting. Nevirapine, efavirenz and rifampicin are known inducers of cytochrome P450 3A4. A technical consultation convened by WHO in June, 2004 concluded that additional research on interactions between antiretroviral and antimalarial drugs is urgently needed.
We propose to perform a suite of pharmacokinetic studies to evaluate these interactions in HIV infected Ugandan patients. The aim of these studies is to evaluate the pharmacokinetic interaction between Coartem® and commonly co-prescribed inducers of 3A4 i.e. nevirapine, efavirenz and rifampicin.
Condition | Intervention | Phase |
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HIV Infections Tuberculosis |
Drug: Lumefantrine-artemether and nevirapine Drug: lumefantrine-artemether and efavirenz Drug: Lumefantrine-artemether and rifampicin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Interaction Between Coartem® and Either Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients |
Estimated Enrollment: | 90 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
nevirapine arm
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Drug: Lumefantrine-artemether and nevirapine
Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive patients receiving nevirapine 200mg twice daily as part of their antiretroviral treatment
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2: Experimental
efavirenz arm
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Drug: lumefantrine-artemether and efavirenz
Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive adults receiving efavirenz tablets 600mg once daily
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3: Experimental
Rifampicin arm
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Drug: Lumefantrine-artemether and rifampicin
Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to patients receiving rifampicin as part of fixed dose combination therapy for tuberculosis
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Concepta A Merry, PhD | 256 414 307224 | cmerry@tcd.ie |
Contact: Pauline Byakika-Kibwika, MMed | 256 414 307224 | pbyakika@gmail.com |
Uganda | |
Infectious Diseases Institute, Makerere University | Recruiting |
Kampala, Uganda, 22418 | |
Sub-Investigator: Pauline Byakika-Kibwika, MMed | |
Sub-Investigator: Mohammed Lamorde, MBBS | |
Sub-Investigator: Moses Kamya, MMed | |
Sub-Investigator: Paul Waako, PhD | |
Sub-Investigator: Abwooli Nyakoojo, MMed | |
Principal Investigator: Concepta Merry, PhD |
Principal Investigator: | Concepta Merry, PhD | Trinity Colleg Dublin |
Responsible Party: | Infectious Diseases Institute, Makerere University ( Concepta Merry ) |
Study ID Numbers: | CPR 005 |
Study First Received: | February 7, 2008 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00620438 |
Health Authority: | Uganda: National Council for Science and Technology |
Lumefantrine Efavirenz Nevirapine Rifampicin HIV |
Benflumetol Bacterial Infections Artemether-lumefantrine combination Efavirenz Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Artemether |
Virus Diseases Rifampin Nevirapine Gram-Positive Bacterial Infections HIV Seropositivity HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections |
Anti-Infective Agents Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Antimalarials Antiparasitic Agents Anti-Retroviral Agents Therapeutic Uses Antifungal Agents Coccidiostats Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Antiplatyhelmintic Agents Enzyme Inhibitors Anthelmintics Antiviral Agents Schistosomicides Pharmacologic Actions Actinomycetales Infections Antibiotics, Antitubercular Lentivirus Infections Antitubercular Agents Leprostatic Agents |