Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001316
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
1999-11-03
Brief Title:
Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in HIV-Infected Individuals
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:
Our laboratory has previously demonstrated that lymph nodes are a major reservoir for human immunodeficiency virus HIV and a major site of active virus replication in infected individuals There is at least a 10 fold greater viral burden per given number of CD4 T lymphocytes obtained from the lymph nodes versus the peripheral blood in the same infected individual These data have been accumulated predominantly in individuals with progressive generalized lymphadenopathy CDC Class A1 and A2 It is unclear at present whether this pattern holds true for all categories of HIV infected individuals We have proposed that the seeding of lymph nodes by HIV early in the course of HIV infection and the persistent production of virus in lymph nodes throughout the course of infection are major factors in the pathogenesis of HIV in virtually all infected individuals In addition it is likely that the selective perturbations of various T cell subsets ie V-B classes of CD4T cells that have been observed in peripheral blood are much more dramatic in the lymph node given the greater viral burden in the lymph node compared to the peripheral blood In order to investigate this hypothesis it is essential that we study simultaneously lymph nodes and peripheral blood from the same individuals and that we study different individuals at various stages of disease from early in the course of infection CDC Class A to advanced disease CDC Class B and C If as we suspect there is active virus replication in the lymph node early in the course of infection even at a time when there is little virus burden or active replication in the peripheral blood this would justify anti-retroviral therapy at the earliest possible time in the course of infection In addition in certain patients who are about to initiate treatment with an anti-retroviral agent such as zidovudine or didanosine through their private physician it would be important to know whether treatment actually reduces the viral burden and virus replication in lymph nodes The effect of therapy on viral burden and replication will be compared in the lymph node versus peripheral blood mononuclear cells and both of these parameters will be compared with the level of plasma viremia
Detailed Description:
We are studying the pathogenesis of HIV infection and other immune dysfunctions Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood and lymphoid tissues cells for studying aspects of either in vivo or in vitro HIV infection A dichotomy exists between the amount of HIV that can be measured in peripheral blood compared to lymphoid tissue as well as the types of immune cells that reside in each compartment We wish to be able to continue to elucidate many pathogenic aspects of HIV infection and other immune dysfunctions using human peripheral blood mononuclear cells and intact tissue or cells obtained from two major lymphoid organs lymph nodes and bone marrow
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 |
|---|---|---|---|
| 92-I-0125 | None | None | None |