Status:
TERMINATED
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
15-45 years
Phase:
NA
Brief 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 uncomplica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00304980
Start Date
March 1 2003
End Date
April 1 2005
Last Update
September 14 2010
Active Locations (1)
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1
Tropical Disease Research Center
Ndola, Cupperbelt, Zambia