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Sponsors and Collaborators: |
U.S. Army Office of the Surgeon General Military Infectious Diseases Research Program (MIDRP) |
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Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
ClinicalTrials.gov Identifier: | NCT00298610 |
The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
Condition | Intervention | Phase |
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Malaria |
Drug: Artesunate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary
Kenya, New Nyanza | |
New Nyanza Provincial Hospital | |
Kisumu, New Nyanza, Kenya |
Principal Investigator: | Shon A Remich, MD | Walter Reed Army Institute of Research (WRAIR) |
Study ID Numbers: | WRAIR 1168, KEMRI 917, HSRRB A-13331 |
Study First Received: | March 1, 2006 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00298610 |
Health Authority: | United States: Food and Drug Administration |
Uncomplicated Malaria GMP artesunate |
Artesunate Protozoan Infections Parasitic Diseases Malaria |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |