Comparative Evaluation of the Safety and the Efficacy of... | NCT00304980

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

NCT00304980

Sponsor

Institute of Tropical Medicine, Belgium

Status

Terminated

Last Update Posted

Sep 14, 2010Estimated

Enrollment

3,000

Phase

Not Applicable

Conditions

Plasmodium Falciparum Malaria

Interventions

ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE

Countries

Zambia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Mar 20, 2006

First Submission Date that Met QC Criteria

Mar 20, 2006

First Posted Date

Mar 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000

Name	Type	Description	Arm Group Labels	Other Names
ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE	Drug

Measure	Description	Time Frame
PCR corrected clinical and parasitological outcome at day 45

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Umberto D'Alessandro, MD,MSc, PHD	Institute of Tropical Medicine Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tropical Disease Research Center		Ndola	Cupperbelt		Zambia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16960779	Result	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.

ID	Term
D008288	Malaria
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

ID	Term
D000077549	Artemether
D011739	Pyrimethamine

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals