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
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

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

ClinicalTrials.gov processed this record on October 29, 2014