Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027482
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-12-07
Brief Title:
Immune Responses to HIV in Blood Cells in HIV-Infected and HIV-Uninfected Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Specific Immune Responses in HIV-Infected and HIV-Uninfected Volunteers
Status:
COMPLETED
Status Verified Date:
2008-08-27
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:
This study will explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time
Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study
Prior to enrollment and yearly thereafter vital signs height and weight will be recorded A medical history will be obtained if relevant to the laboratory research for which the sample will be used A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician A complete blood count will be performed on the day of enrollment and yearly thereafter Samples will be collected in the following manner
Blood will be drawn from a needle in an arm vein one or more times during the course of the study From 20 to 150 cc 4 to 30 teaspoonfuls of blood will be collected at a time No more than 450 cc less than 1 pint of blood will be drawn during any 6-week period
Urine and saliva samples will be collected by the volunteer in private
Swab samples will be collected by a nurse or doctor using a cotton swab to brush inside the mouth
Samples may be used for the following tests
Hepatitis and other viral screening-This may include screening for different types of viral liver infections such as hepatitis A B C D E or G for cytomegalovirus related to the herpes virus and for varicella zoster virus responsible for chicken pox in children and shingles in adults
Genetic testing-DNA in blood cells may be examined for genetic mutations physical or chemical changes or deletions missing pieces that affect substances involved in the bodys ability to mount an inflammatory immune response Alterations in the genes for some of these substances have been shown to influence HIV infection
HLA testing-HLA type is a genetic marker of the immune system Determining HLA type is necessary in order to do certain research studies Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions
Other laboratory tests as clinically indicated or required for research needs
Some samples collected in this study may be stored for future researchThey will be labeled without identifying information
Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions
Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study
Prior to enrollment and yearly thereafter vital signs height and weight will be recorded A medical history will be obtained if relevant to the laboratory research for which the sample will be used A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician A complete blood count will be performed on the day of enrollment and yearly thereafter Samples will be collected in the following manner
Blood will be drawn from a needle in an arm vein one or more times during the course of the study From 20 to 150 cc 4 to 30 teaspoonfuls of blood will be collected at a time No more than 450 cc less than 1 pint of blood will be drawn during any 6-week period
Urine and saliva samples will be collected by the volunteer in private
Swab samples will be collected by a nurse or doctor using a cotton swab to brush inside the mouth
Samples may be used for the following tests
Hepatitis and other viral screening-This may include screening for different types of viral liver infections such as hepatitis A B C D E or G for cytomegalovirus related to the herpes virus and for varicella zoster virus responsible for chicken pox in children and shingles in adults
Genetic testing-DNA in blood cells may be examined for genetic mutations physical or chemical changes or deletions missing pieces that affect substances involved in the bodys ability to mount an inflammatory immune response Alterations in the genes for some of these substances have been shown to influence HIV infection
HLA testing-HLA type is a genetic marker of the immune system Determining HLA type is necessary in order to do certain research studies Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions
Other laboratory tests as clinically indicated or required for research needs
Some samples collected in this study may be stored for future researchThey will be labeled without identifying information
Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions
Detailed Description:
The Vaccine Research Center VRC is studying specific immune responses to HIV infection and other pathogens in order to characterize protective responses that can prevent new infection in uninfected individuals as well as define those responses that lead to successful control of viral replication in persons already infected with the pathogen We wish to define the specific human immune responses to HIV infection other pathogens and vaccines using human peripheral blood mononuclear cells plasma serum urine or oral secretions as a model
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 |
|---|---|---|---|
| 02-I-0066 | None | None | None |