NCT00304980

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

First QC Date

March 20, 2006

Last Update Submit

September 12, 2010

Conditions

Plasmodium Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

  • PCR corrected clinical and parasitological outcome at day 45

Secondary Outcomes (2)

  • Tolerability

  • Clinical recovery

Interventions

ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINEDRUG

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Disease Research Center

Ndola, Cupperbelt, Zambia

Location

Related 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 uncomplicated malaria. J Infect Dis. 2006 Oct 1;194(7):917-25. doi: 10.1086/507310. Epub 2006 Aug 29.

    PMID: 16960779RESULT

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

ArtemetherPyrimethamine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Umberto D'Alessandro, MD,MSc, PHD

    Institute of Tropical Medicine Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

March 1, 2003

Study Completion

April 1, 2005

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

ZA(1)