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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00304980
Other study ID # 02 52 5 406
Secondary ID
Status Terminated
Phase N/A
First received March 20, 2006
Last updated September 12, 2010
Start date March 2003
Est. completion date April 2005

Study information

Verified date September 2010
Source Institute of Tropical Medicine, Belgium
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3000
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE


Locations

Country Name City State
Zambia Tropical Disease Research Center Ndola Cupperbelt

Sponsors (1)

Lead Sponsor Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

Van Geertruyden JP, Mulenga M, Mwananyanda L, Chalwe V, Moerman F, Chilengi R, Kasongo W, Van Overmeir C, Dujardin JC, Colebunders R, Kestens L, D'Alessandro U. HIV-1 immune suppression and antimalarial treatment outcome in Zambian adults with uncomplicat — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PCR corrected clinical and parasitological outcome at day 45
Secondary Tolerability
Secondary Clinical recovery
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