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

Plasmodium Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00304980
• Other study ID #: 02 52 5 406
• 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
• 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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

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