Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
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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 or disease
Plasmodium Falciparum Malaria
Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
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
Study Start Date
Estimated Study Completion Date
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Ages Eligible for Study:
15 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.