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

Primary Purpose

Malaria, HIV, AIDS

Status
Completed
Phase
Phase 4
Locations
Kenya
Study Type
Interventional
Intervention
sulfadoxine-pyrimethamine
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, HIV, AIDS, drug efficacy, Kenya, Africa, Sulfadoxine pyirmethamine, fansidar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CDC KEMRI Research Institute

Outcomes

Primary Outcome Measures

Drug failure

Secondary Outcome Measures

Full Information

First Posted
September 2, 2005
Last Updated
September 2, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
Kenya Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00144352
Brief Title
In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults
Official Title
The in-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Individuals-a 28 Day Efficacy Trial Involving HIV+ and HIV- Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Kenya Medical Research Institute

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, HIV, AIDS
Keywords
Malaria, HIV, AIDS, drug efficacy, Kenya, Africa, Sulfadoxine pyirmethamine, fansidar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
540 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sulfadoxine-pyrimethamine
Primary Outcome Measure Information:
Title
Drug failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snehal Shah, MD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC KEMRI Research Institute
City
Kisumu
Country
Kenya

12. IPD Sharing Statement

Learn more about this trial

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

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