Trial | NCT00304980  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    3000
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.
Study Started
Mar 31
2003
Study Completion
Apr 30
2005
Last Update
Sep 14
2010
Estimate

Drug ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE

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.
No Results Posted