NCT00144352

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

September 5, 2005

Status Verified

September 1, 2005

First QC Date

September 2, 2005

Last Update Submit

September 2, 2005

Conditions

MalariaHIVAIDS

Keywords

MalariaHIVAIDSdrug efficacyKenyaAfricaSulfadoxine pyirmethaminefansidar

Outcome Measures

Primary Outcomes (1)

  • Drug failure

Interventions

sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDC KEMRI Research Institute

Kisumu, Kenya

Location

MeSH Terms

Conditions

MalariaAcquired Immunodeficiency Syndrome

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Snehal Shah, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

September 1, 2002

Study Completion

July 1, 2004

Last Updated

September 5, 2005

Record last verified: 2005-09

Locations

KE(1)