Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144352
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2005-09-02
Brief Title:
In-Vivo Response of P Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 123471421 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCC644 | None | None | None |
| UR6CCU018970-02-2 | None | None | None |