Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
This study has been terminated.
Sponsor:
Institute of Tropical Medicine, Belgium
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00304980
First received: March 20, 2006
Last updated: September 12, 2010
Last verified: September 2010
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Purpose
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
| Condition | Intervention |
|---|---|
|
Plasmodium Falciparum Malaria |
Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia |
Resource links provided by NLM:
Further study details as provided by Institute of Tropical Medicine, Belgium:
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Man and non-pregnant women aged between 15 and 50.
- P.falciparum mono-infection of at least 1,000 parasites/µl.
- Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- Consent from patient obtained.
Exclusion Criteria:
- Pregnancy.
- Severe P. falciparum malaria .
- Documented intake of SP or Coartem two weeks or less prior recruitment.
- Other cause(s) of fever.
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
- History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304980
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304980
Locations
| Zambia | |
| Tropical Disease Research Center | |
| Ndola, Cupperbelt, Zambia | |
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Investigators
| Principal Investigator: | Umberto D'Alessandro, MD,MSc, PHD | Institute of Tropical Medicine, Antwerp |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00304980 History of Changes |
| Other Study ID Numbers: | 02 52 5 406 |
| Study First Received: | March 20, 2006 |
| Last Updated: | September 12, 2010 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Malaria, Falciparum Malaria Parasitic Diseases Protozoan Infections Artemether-lumefantrine combination Artemisinins Fanasil, pyrimethamine drug combination Lumefantrine Pyrimethamine Sulfadoxine Anti-Infective Agents |
Anti-Infective Agents, Urinary Antimalarials Antiparasitic Agents Antiprotozoal Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Renal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015