Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000900
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Effects of Illnesses on HIV Levels in the Body
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Impact of Intercurrent Illness on HIV Viral Load
Status:
COMPLETED
Status Verified Date:
1999-04
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:
To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an acute febrile illness To identify factors associated with increases ie type of illness ultimately diagnosed bacterial viral fungal CD4 cell count and antiretroviral treatment regimen To describe changes in phenotypic markers of immune activationdysregulation of CD4 and CD8 lymphocyte subsets and their relationship to intercurrent illness To describe changes in plasma cytokines and soluble activation markers and their relationship to plasma HIV-1 viremia during and after the onset of intercurrent illness To characterize the viral biologic phenotype and the viral drug susceptibility genotype before during and after the onset of an acute febrile illness To characterize the expression of HIV-1 co-receptors before during and after the onset of an acute febrile illness Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load viral HIV-1 phenotypes viral HIV-1 genotypes and T cell phenotypes Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation plasma cytokine levels phenotypic and genotypic changes in circulating virus and HIV-1 tropisms
Detailed Description:
Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load viral HIV-1 phenotypes viral HIV-1 genotypes and T cell phenotypes Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation plasma cytokine levels phenotypic and genotypic changes in circulating virus and HIV-1 tropisms
This is a study to determine whether patients exhibit a temporary burst of viral replication or other changes in response to intercurrent febrile illness Although there is no study treatment patients on this study must be co-enrolled in at least 1 other ACTG antiretroviral treatment study Plasma HIV-1 RNA and other variables are measured at the time of presentation on Day 3 and at Weeks 1 2 4 8 16 and 24
This is a study to determine whether patients exhibit a temporary burst of viral replication or other changes in response to intercurrent febrile illness Although there is no study treatment patients on this study must be co-enrolled in at least 1 other ACTG antiretroviral treatment study Plasma HIV-1 RNA and other variables are measured at the time of presentation on Day 3 and at Weeks 1 2 4 8 16 and 24
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: