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

This study has been terminated.
Sponsor:
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
  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:

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

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
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
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Artemether
Sulfadoxine-pyrimethamine
Lumefantrine
Artemether-lumefantrine combination
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on April 16, 2014