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Sponsors and Collaborators: |
University of Cape Town London School of Hygiene and Tropical Medicine |
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Information provided by: | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00790881 |
Despite the clinical significance of potential interactions between antimalarials and antiretrovirals, no drug interaction studies have been published and there is an urgent need to address this gap in current knowledge. This study aims to assess the drug interaction between the antimalarial Artemether/Lumefantrine used for management of uncomplicated malaria and Nevirapine-based antiretroviral therapy.
Condition | Intervention | Phase |
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Malaria HIV |
Drug: Artemether/Lumefantrine Drug: Artemether/ lumefantrine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Nevirapine in HIV-Infected Adults |
Estimated Enrollment: | 36 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Antiretroviral-naive
Antiretroviral-naive included as control group
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Drug: Artemether/Lumefantrine
Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours
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Nevirapine-based antiretroviral therapy: Active Comparator
Nevirapine-based antiretroviral therapy
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Drug: Artemether/ lumefantrine
Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to artemether/lumefantrine:
III, neuroleptics, antidepressive agents, certain antibiotics including some agents of the following classes:
macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride.
Contraindication to nevirapine:
Pharmacokinetic exclusion criteria:
General exclusion criteria:
Contact: Tamara Kredo, MD | +27 21 4066779 | tamara.kredo@uct.ac.za |
Contact: Karen Barnes, MD PhD | +27 21 4066759 | karen.barnes@uct.ac.za |
South Africa, Western Province | |
Groote Schuur Hospital, ward J51, OMB | Recruiting |
Cape Town, Western Province, South Africa, 8001 | |
Contact: Tamara Kredo, MD +27 21 4066779 tamara.kredo@uct.ac.za | |
Sub-Investigator: Tamara Kredo, MD |
Principal Investigator: | Karen Barnes, MD | University of Cape Town |
Study Director: | Tamara Kredo, MD | University of Cape Town |
Responsible Party: | London School of Hygiene & Tropical Medicine ( ACT Consortium ) |
Study ID Numbers: | SEACAT 2.4.1, DOH-27-0807-2012 |
Study First Received: | November 13, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00790881 History of Changes |
Health Authority: | South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council |
malaria HIV AIDS nevirapine |
lumefantrine artemether drug interaction pharmacokinetics |
Benflumetol Protozoan Infections Artemether-lumefantrine combination Anti-Infective Agents Anti-HIV Agents Acquired Immunodeficiency Syndrome Malaria Anthelmintics Antiviral Agents |
Reverse Transcriptase Inhibitors Artemether Antimalarials Nevirapine Anti-Retroviral Agents HIV Infections Antifungal Agents Parasitic Diseases |
Benflumetol Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Malaria Artemether Reverse Transcriptase Inhibitors Antimalarials Antiparasitic Agents Anti-Retroviral Agents Therapeutic Uses Antifungal Agents Parasitic Diseases |
Coccidiostats Nucleic Acid Synthesis Inhibitors Artemether-lumefantrine combination Protozoan Infections Anti-HIV Agents Coccidiosis Antiplatyhelmintic Agents Anthelmintics Enzyme Inhibitors Schistosomicides Antiviral Agents Pharmacologic Actions Nevirapine |