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Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status

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ClinicalTrials.gov Identifier: NCT00304980
Recruitment Status : Terminated
First Posted : March 21, 2006
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Institute of Tropical Medicine, Belgium

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2003
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Malaria
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. PCR corrected clinical and parasitological outcome at day 45

Secondary Outcome Measures :
  1. Tolerability
  2. Clinical recovery

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00304980     History of Changes
Other Study ID Numbers: 02 52 5 406
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Pyrimethamine
Sulfadoxine
Artemether-lumefantrine combination
Artemisinins
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents