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.

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.