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

March 20, 2006
September 12, 2010
March 2003
Not Provided
PCR corrected clinical and parasitological outcome at day 45
Same as current
Complete list of historical versions of study NCT00304980 on ClinicalTrials.gov Archive Site
  • Tolerability
  • Clinical recovery
Same as current
Not Provided
Not Provided
 
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Plasmodium Falciparum Malaria
Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
Not Provided
Van Geertruyden JP, Mulenga M, Mwananyanda L, Chalwe V, Moerman F, Chilengi R, Kasongo W, Van Overmeir C, Dujardin JC, Colebunders R, Kestens L, D'Alessandro U. HIV-1 immune suppression and antimalarial treatment outcome in Zambian adults with uncomplicated malaria. J Infect Dis. 2006 Oct 1;194(7):917-25. Epub 2006 Aug 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3000
April 2005
Not Provided

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.
Both
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00304980
02 52 5 406
Not Provided
Not Provided
Institute of Tropical Medicine, Belgium
Not Provided
Principal Investigator: Umberto D'Alessandro, MD,MSc, PHD Institute of Tropical Medicine, Antwerp
Institute of Tropical Medicine, Belgium
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP