Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001681
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations
Status:
COMPLETED
Status Verified Date:
1999-10
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:
The factors that influence HIV disease progression are not well understood While larger amounts of circulating virus high viral loads predict future adverse clinical events many of the clinical factors responsible for high viral loads and disease progression remain unknown Certain clinical events and defined interventions are associated with increases in plasma viral RNA concentrations One of these clinical interventions is immunization immunization with several vaccines have been shown to increase plasma HIV RNA concentrations Even though vaccination can lead to transient increases in plasma HIV concentrations certain vaccines including influenza vaccine are still recommended for HIV patients because the risks of the disease targeted by the immunization are held to be greater than the immunization itself Therefore immunization with influenza vaccine can be considered a model clinically indicated intervention given at a known time which stimulates HIV replication For influenza immunization and for other treatments leading to increases in viral RNA concentrations is not available We hypothesize that immunization with influenza vaccine and perhaps other immune stimulatory events lead to an increase in HIV replication through a regulatory system involving cytokines signal transduction systems transcription factors effects on the cell cycle and increased expression of additional gene products needed for viral replication such as genes of the nucleic acid biosynthetic pathways While experiments aimed at investigating one or another particular part of this regulatory system can be performed with traditionally available technologies such technologies cannot provide comprehensive information concerning a large number of the regulatory events that may be involved in mediating the increase in HIV RNA concentration In this protocol we aim to develop the methodologies needed to determine changes in expression of many of the genes which may be involved in mediating the regulation of HIV expression in HIV-infected patients using cDNA microarray technologies Once the methodologies are developed such work may provide new insights into the regulatory systems controlling HIV expression in HIV-infected patients may provide new insights into the pathogenesis of HIV disease
Detailed Description:
The factors that influence HIV disease progression are not well understood While larger amounts of circulating virus high viral loads predict future adverse clinical events many of the clinical factors responsible for high viral loads and disease progression remain unknown Certain clinical events and defined interventions are associated with increases in plasma viral RNA concentrations One of these clinical interventions is immunization immunization with several vaccines have been shown to increase plasma HIV RNA concentrations Even though vaccination can lead to transient increases in plasma HIV concentrations certain vaccines including influenza vaccine are still recommended for HIV patients because the risks of the disease targeted by the immunization are held to be greater than the immunization itself Therefore immunization with influenza vaccine can be considered a model clinically indicated intervention given at a known time which stimulates HIV replication For influenza immunization and for other treatments leading to increases in viral RNA concentrations detailed knowledge of the regulatory events that mediate the increase in RNA concentrations is not available We hypothesize that immunization with influenza vaccine and perhaps other immune stimulatory events lead to an increase in HIV replication through a regulatory system involving cytokines signal transduction systems transcription factors effects on the cell cycle and increased expression of additional gene products needed for viral replication such as genes of the nucleic acid biosynthetic pathways While experiments aimed at investigating one or another particular part of this regulatory system can be performed with traditionally available technologies such technologies cannot provide comprehensive information concerning a large number of the regulatory events that may be involved in mediating the increase in HIV RNA concentration In this protocol we aim to develop the methodologies needed to determine changes in expression of many of the genes which may be involved in mediating the regulation of HIV expression in HIV-infected patients using cDNA microarray technologies Once the methodologies are developed such work may provide new insights into the regulatory systems controlling HIV expression in HIV-infected patients may provide new insights into the pathogenesis of HIV disease
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 |
|---|---|---|---|
| 98-C-0011 | None | None | None |