Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001281
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
1999-11-03
Brief Title:
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells andor Body Fluids in People Living With and Without HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells andor Body Fluids in People Living With and Without HIV
Status:
RECRUITING
Status Verified Date:
2024-10-22
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 purpose of this this study is to learn more about the immune system how it responds to infections like HIV and to learn more about conditions that may decrease your immune system s ability to fight infections The primary procedure to be performed is venipuncture and blood drawing The blood will be used for a variety of studies looking at immune dysfunctions and at the effects of HIV or other infectious and noninfectious conditions on the production of factors by immune cells In addition the cells in the blood may be screened for genes that have missing pieces or changes in them that can affect their function This will help us evaluate specific immune responses for research purposes This study will examine the effects of HIV infection on substances produced by immune cells that increase or decrease HIV infection
Both people living with and without HIV may be eligible for this study Participants will be required to have a yearly medical evaluation including blood tests for cell counts and chemistries a blood or urine pregnancy test for women and other laboratory tests as medically indicated or for research purposes
Participants will donate blood or reproductive fluids or both From 20 to 150 cc 4 to 30 teaspoonfuls of blood will be drawn from the arm using a small needle Participants may be asked to provide blood samples on more than one occasion over the course of the study No more than 450 cc less than 1 pint of blood will be drawn during any 6-week period Males will be given a private room for semen donation fluid from females will be collected with a cotton swab after speculum insertion Participants may also be asked to have a buccal swab For this procedure the inside of the cheek is gently scraped with a blunt-ended stick or brush to obtain cells buccal mucosal cells The tissues will be used for a variety of studies on the effects of HIV infection on factors that increase or decrease HIV infection
Some of the tissues collected for this study may also be used for the following tests
Hepatitis screening Blood may be screened for different types of viral liver infections such as hepatitis A B C D E or G
Genetic testing We will use genetic tests that focus on specific genes that can affect how the immune system works or to learn more about HIV and other conditions being studied We may test the DNA in the cells in the blood or in cheek cells for the presence of mutations or deletions These alterations may be sought in genes encoding factors that are linked to the immune system s ability to fight infection and prevent disease or factors that allow HIV and other infectious agents to cause infection from blood or cheek cells may be examined for mutations or deletions that affect chemokines cytokines and a family of enzymes called caspases Chemokines and cytokines are important mediators of the immune response Alterations in the genes for some of these substances influence HIV infection
HLA testing Blood may be tested for HLA type-a genetic marker of the immune system These tests may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions Determining HLA type is necessary to be able to perform certain research studies Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems
Both people living with and without HIV may be eligible for this study Participants will be required to have a yearly medical evaluation including blood tests for cell counts and chemistries a blood or urine pregnancy test for women and other laboratory tests as medically indicated or for research purposes
Participants will donate blood or reproductive fluids or both From 20 to 150 cc 4 to 30 teaspoonfuls of blood will be drawn from the arm using a small needle Participants may be asked to provide blood samples on more than one occasion over the course of the study No more than 450 cc less than 1 pint of blood will be drawn during any 6-week period Males will be given a private room for semen donation fluid from females will be collected with a cotton swab after speculum insertion Participants may also be asked to have a buccal swab For this procedure the inside of the cheek is gently scraped with a blunt-ended stick or brush to obtain cells buccal mucosal cells The tissues will be used for a variety of studies on the effects of HIV infection on factors that increase or decrease HIV infection
Some of the tissues collected for this study may also be used for the following tests
Hepatitis screening Blood may be screened for different types of viral liver infections such as hepatitis A B C D E or G
Genetic testing We will use genetic tests that focus on specific genes that can affect how the immune system works or to learn more about HIV and other conditions being studied We may test the DNA in the cells in the blood or in cheek cells for the presence of mutations or deletions These alterations may be sought in genes encoding factors that are linked to the immune system s ability to fight infection and prevent disease or factors that allow HIV and other infectious agents to cause infection from blood or cheek cells may be examined for mutations or deletions that affect chemokines cytokines and a family of enzymes called caspases Chemokines and cytokines are important mediators of the immune response Alterations in the genes for some of these substances influence HIV infection
HLA testing Blood may be tested for HLA type-a genetic marker of the immune system These tests may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions Determining HLA type is necessary to be able to perform certain research studies Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems
Detailed Description:
We are studying virologic andor immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 91-I-0140 | None | None | None |