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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304980
First Posted: March 21, 2006
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Tropical Medicine, Belgium
  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
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

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • PCR corrected clinical and parasitological outcome at day 45

Secondary Outcome Measures:
  • Tolerability
  • Clinical recovery

Estimated Enrollment: 3000
Study Start Date: March 2003
Estimated Study Completion Date: April 2005
  Eligibility

Information from the National Library of Medicine

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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
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

Publications:
ClinicalTrials.gov Identifier: NCT00304980     History of Changes
Other Study ID Numbers: 02 52 5 406
First Submitted: March 20, 2006
First Posted: March 21, 2006
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


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