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

• Status: Terminated
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Fanasil, pyrimethamine drug combination; Lumefantrine; Pyrimethamine; Sulfadoxine

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.