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In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults

NCT ID: NCT00144352

Last Updated: 2005-09-05

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-07-31

Brief Summary

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Plasmodium falciparum malaria and HIV are among the most important infectious diseases in sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa, resulting in approximately 1 million deaths, mostly in children under five years of age. It is clear that HIV and malaria are responsible for substantial disease, suffering, and an enormous economic burden on the people who can least afford it. Although a study in 1993 in Tanzania showed significantly higher prevalence of malaria infections in HIV-positive compared to HIV negative adults, until recently there have been few studies showing any association between the two infections.

We conducted a study to measure the efficacy of the then-first line antimalarial drug (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative, those who were HIV infected with CD4 cell counts \< 200, and among HIV infected patients with CD4 cell counts \>= 200. Our hypothesis is that patients with HIV infection and low CD4 cell count will not respond to antimalarial therapy as well as patients who are HIV infected with higher CD4 cell counts or who are HIV negative.

Detailed Description

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The study was conducted at Siaya District Hospital, in Nyanza Province, Kenya. Non-pregnant adults who provided consent to participate, who were found to have pure Plasmodium falciparum malaria parasitemia with at least 500 asexual parasites per microliter, and who agreed to undergo HIV counseling and testing were eligible for participation. Clients were then followed with repeat physical examinations and blood smears on day 1,2,3,4,7,14,21 and 28 and any non-scheduled day when they were sick. Those that failed therapy were treated with quinine to clear parasitemia. Samples were also taken to measure reinfection vs. recrudescence, pharmacokinetics, and antifolate resistance markers.

Conditions

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Malaria HIV AIDS

Keywords

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Malaria HIV AIDS drug efficacy Kenya Africa Sulfadoxine pyirmethamine fansidar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sulfadoxine-pyrimethamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

18 years of age or older, not pregnant. Are able to make all follow-up visits. Are able to understand and give informed consent. Have a history of fever in past 24hrs or current axillary temperature of ³ 37.5C.

Have an unmixed infection with P. falciparum of at least 500 asexual parasites/mm3 as determined by microscopic examination of thick and/or thin peripheral blood smears.

Do not have any evidence of severe or complicated malaria (e.g., cerebral malaria, Hb \< 5 g/dL, signs and symptoms of congestive heart failure) that would require hospitalisation for treatment.

Have no reported allergy to sulfa drugs. Agree to HIV testing and receiving the results.

Exclusion Criteria

Less than 18 yrs old. Pregnant. History of allergic reactions to sulfa drugs. Have severe or complicated malaria. No history of fever. Plan to leave Siaya in next month. Do not agree to HIV testing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Snehal Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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CDC KEMRI Research Institute

Kisumu, , Kenya

Site Status

Countries

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Kenya

Other Identifiers

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UR6/CCU018970-02-2

Identifier Type: -

Identifier Source: secondary_id

SCC#644

Identifier Type: -

Identifier Source: secondary_id

CDC-NCID-3537

Identifier Type: -

Identifier Source: org_study_id