Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039689
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2002-06-06
Brief Title:
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral-Naive HIV-Infected Patients
Status:
RECRUITING
Status Verified Date:
2024-10-01
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:
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection This study will use leukapheresis drawing blood separating out the white cells and returning the blood to the patient to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy HAART Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4 T cell help the CD8 factors associated with suppression of viral replication and normalization of immune function and natural killer function relative to HIV disease
Study participants will be adult older than 18 years HIV primary or acutely affected patients those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease and HIV chronically infected patients those infected with HIV for longer than 12 months or showing other symptoms of HIV disease who are not receiving HAART at the beginning of the study The study seeks to enroll 30 primary and 30 chronic patients Pregnant women will not be enrolled in the study women who become pregnant will be dropped from the study
Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year Each session will take between 1 and 3 hours
This longitudinal study will enable researchers to examine the function of certain B cells natural killer cells and CD8 T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART
Study participants will be adult older than 18 years HIV primary or acutely affected patients those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease and HIV chronically infected patients those infected with HIV for longer than 12 months or showing other symptoms of HIV disease who are not receiving HAART at the beginning of the study The study seeks to enroll 30 primary and 30 chronic patients Pregnant women will not be enrolled in the study women who become pregnant will be dropped from the study
Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year Each session will take between 1 and 3 hours
This longitudinal study will enable researchers to examine the function of certain B cells natural killer cells and CD8 T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART
Detailed Description:
HIV infection is known to cause profound and irreversible dysfunction of both innate and adaptive arms of the immune system However there is mounting evidence that early and aggressive treatment with antiretroviral drugs can prevent loss of immune cell function In an attempt to further delineate the effect of early antiretroviral therapy ART on maintenance of immune cell function we wish to recruit drug-naive HIV-infected patients who are either in early or chronic stage of infection The study will require that patients undergo leukapheresis or research blood draw once before and several times after enrollment Leukapheresis will be used in order to obtain sufficient cells to pursue the following objectives delineating B cell response to CD4T cell help delineating the effect of ART on persistent HIV reservoirs in CD4T cells of infected individuals and delineating CD8T cell-mediated suppression of viral replication and normalization of immune function and characterizing natural killer NK function relative to HIV disease The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis procedures in the Clinical Center Apheresis Unit This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have leukapheresis procedures but the protocol by itself is not an independent research study Alternatively whole blood draws may be used in cases where patients are unable to undergo leukapheresis While this approach will limit extensive functional analyses informative phenotypic and limited functional analyses can nonetheless be performed
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 |
|---|---|---|---|
| 02-I-0202 | None | None | None |