Back to resultsComparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
Primary Purpose
Plasmodium Falciparum Malaria
Status
Terminated
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
Sponsored by
About this trial
This is an interventional treatment trial for Plasmodium Falciparum Malaria
Eligibility 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.
Sites / Locations
- Tropical Disease Research Center
Outcomes
Primary Outcome Measures
PCR corrected clinical and parasitological outcome at day 45
Secondary Outcome Measures
Tolerability
Clinical recovery
Full Information
NCT ID
NCT00304980
First Posted
March 20, 2006
Last Updated
September 12, 2010
Sponsor
Institute of Tropical Medicine, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00304980
Brief Title
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Tropical Medicine, Belgium
4. Oversight
5. Study Description
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 uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
Primary Outcome Measure Information:
Title
PCR corrected clinical and parasitological outcome at day 45
Secondary Outcome Measure Information:
Title
Tolerability
Title
Clinical recovery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto D'Alessandro, MD,MSc, PHD
Organizational Affiliation
Institute of Tropical Medicine Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Disease Research Center
City
Ndola
State/Province
Cupperbelt
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16960779
Citation
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 uncomplicated malaria. J Infect Dis. 2006 Oct 1;194(7):917-25. doi: 10.1086/507310. Epub 2006 Aug 29.
Results Reference
result
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Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
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