Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029445
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2002-01-11
Brief Title:
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients Including Long-term Non-progressors
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Viral Factors and Immune Parameters to Study HIV-Specific Immunity
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:
This study will collect white blood cells and plasma for research on how the immune system controls HIV infection The immune system of a very small group of HIV-infected patients called non-progressors has been able to control HIV for long periods without antiretroviral therapy Some immune system-related genes important for this control have been identified in these patients This study will examine the contribution of HLA genes B57 B27 and A01 to HIV disease in progressors and long-term non-progressors HLA type is a genetic marker of the immune system
HIV-infected patients 18 years of age and older with HLA types B57 B27 andor A01 may be eligible for this study
Participants will undergo apheresis-a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw-by one of the following two methods
Automated pheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine separating the blood components The white cells are extracted and the red cells with or without plasma liquid part of the blood are re-infused into the donor through the same needle or a needle in the other arm An anticoagulant medication to prevent blood from clotting is usually added to the blood while in the machine to prevent it from clotting during processing
Manual pheresis - One unit 1 pint of blood is drawn through a needle placed in an arm vein similar to donating a pint of whole blood The red blood cells with or without plasma are separated from the rest of the blood and re-infused to the donor through the same needle Manual pheresis will be done only when a person s estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine An adult small in size or markedly anemic for example may fall into this category
Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing a genetic test of markers of the immune system Some of the blood may be used to screen for different types of viral liver infections such as hepatitis A B C D E F or G
HIV-infected patients 18 years of age and older with HLA types B57 B27 andor A01 may be eligible for this study
Participants will undergo apheresis-a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw-by one of the following two methods
Automated pheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine separating the blood components The white cells are extracted and the red cells with or without plasma liquid part of the blood are re-infused into the donor through the same needle or a needle in the other arm An anticoagulant medication to prevent blood from clotting is usually added to the blood while in the machine to prevent it from clotting during processing
Manual pheresis - One unit 1 pint of blood is drawn through a needle placed in an arm vein similar to donating a pint of whole blood The red blood cells with or without plasma are separated from the rest of the blood and re-infused to the donor through the same needle Manual pheresis will be done only when a person s estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine An adult small in size or markedly anemic for example may fall into this category
Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing a genetic test of markers of the immune system Some of the blood may be used to screen for different types of viral liver infections such as hepatitis A B C D E F or G
Detailed Description:
In an attempt to elucidate the mechanisms of immune-mediated restriction of HIV viral replication we aim to study three groups of individuals
1 HIV-infected long-term nonprogressors LTNP who appear to control HIV primarily through virus-specific cellular immunity
2 HIV-infected participants who have broadly cross-neutralizing antibody activity against HIV and
3 the family members of participants exhibiting immunologic control of HIV infection Although most of our previous efforts have focused on investigating the virus-specific immune responses in a unique group of patients termed LTNP who control HIV by cellular immune-mediated mechanisms more recently another group of rare individuals who naturally develop broadly cross-neutralizing antibody activity against HIV isolates have also been identified in our laboratory Passive transfer studies in nonhuman primates have demonstrated that neutralizing antibodies detectable in a subject at the time of challenge can protect from infection We aim to recruit more of these participants in an effort to further characterize and compare their virus-specific cellular and humoral immune responses with those in individuals experiencing progressive infection As we attain greater insight into differences between these participant groups we hope to perform genetic studies that would enable us to more precisely identify susceptibility or protective genes which could be potentially used to construct a familial pedigree We anticipate that all of these findings will contribute to an enhanced understanding of the nature of effective HIVspecific humoral and cellular immunity which will help focus future vaccine design efforts For our studies it will be necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit This protocol is designed to conform to the requirements of the Apheresis Unit for donors to have leukapheresis or plasmapheresis procedures In select subjects lymphocytes obtained from lymph node biopsy will also be studied
1 HIV-infected long-term nonprogressors LTNP who appear to control HIV primarily through virus-specific cellular immunity
2 HIV-infected participants who have broadly cross-neutralizing antibody activity against HIV and
3 the family members of participants exhibiting immunologic control of HIV infection Although most of our previous efforts have focused on investigating the virus-specific immune responses in a unique group of patients termed LTNP who control HIV by cellular immune-mediated mechanisms more recently another group of rare individuals who naturally develop broadly cross-neutralizing antibody activity against HIV isolates have also been identified in our laboratory Passive transfer studies in nonhuman primates have demonstrated that neutralizing antibodies detectable in a subject at the time of challenge can protect from infection We aim to recruit more of these participants in an effort to further characterize and compare their virus-specific cellular and humoral immune responses with those in individuals experiencing progressive infection As we attain greater insight into differences between these participant groups we hope to perform genetic studies that would enable us to more precisely identify susceptibility or protective genes which could be potentially used to construct a familial pedigree We anticipate that all of these findings will contribute to an enhanced understanding of the nature of effective HIVspecific humoral and cellular immunity which will help focus future vaccine design efforts For our studies it will be necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit This protocol is designed to conform to the requirements of the Apheresis Unit for donors to have leukapheresis or plasmapheresis procedures In select subjects lymphocytes obtained from lymph node biopsy will also be studied
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-0086 | None | None | None |