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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plasmodium Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Umberto D'Alessandro, MD,MSc, PHD

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine Antwerp

Locations

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Tropical Disease Research Center

Ndola, Cupperbelt, Zambia

Site Status

Countries

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Zambia

References

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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.

Reference Type RESULT

PMID: 16960779 (View on PubMed)

Other Identifiers

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02 52 5 406

Identifier Type: -

Identifier Source: org_study_id