Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status

Institute of Tropical Medicine, Belgium

Status

Terminated

Conditions

Plasmodium Falciparum Malaria

Treatments

Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE

Study type

Interventional

Funder types

Other

Identifiers

NCT00304980

02 52 5 406

Details and patient eligibility

About

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.

Sex

All

Ages

15 to 45 years old

Volunteers

No Healthy Volunteers

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.