Viral Load in Blood and Lymph Tissues in People Living With HIV

Recruiting

• Conditions: HIV

• Registration Number: NCT00001316
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This is a study to determine the effect of the human immunodeficiency virus (HIV) on lymphoid tissues (e.g., lymph nodes) as compared to peripheral white blood cells. We have shown in previous studies that the lymph node is a major site of accumulation of HIV in the body, as well as being a site where much of the viral replication occurs which leads to the destruction of the body's immune system. To better understand the role of the lymph node in HIV infection and destruction of one s immunity, we wish to examine both the virus itself as well as the effects it is having on various types of white cells (called lymphocytes) obtained simultaneously from both peripheral blood and lymph nodes of people living with HIV (PLWH). We also need to look at cells derived from blood and lymph nodes from people who do not have HIV to serve as a control for experiments. We may also use your lymph node tissue and blood cells to attempt to make new T-cells, or rebuild the immune cells, in the laboratory by adding various factors or other substances released by different cells in the body. If you are living with HIV, you may be asked to undergo a second biopsy six weeks to 12 months after the first biopsy. Because of the ability of aspirin to interfere with blood clotting, you must have refrained from the use of aspirin for one week (7 days) prior to the biopsy date. You also cannot use non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g., ibuprofen, naproxen, and similar drugs) one week (7 days) prior to the biopsy. In addition, pregnancy testing will be performed on all females at the time of admission and a positive test will exclude you from participation. No participant will undergo more than six biopsies while participating in this study unless a particular research requires it.

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 Timeline

• Study Start: 1992-08-26
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2025-02-28
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative burden of HIV	Throughout	The purpose of this project is to determine the relative burden of human immunodeficiency virus (HIV) and/or associated changes in hematopoiesis and immune activation as well as HIV-specific responses in the various subsets of peripheral blood mononuclear cells versus the lymphoid tissues (LT) and bone marrow (BM) in people living with HIV (PLWH).
Immunoregulatory mechanisms	Throughout	We wish to delineate the precise nature of the immunoregulatory mechanisms and altered homing patterns that contribute to the perturbations in the phenotype and functions of various lymphocyte subsets in peripheral blood versus the lymphoid tissues (LT) of people living with HIV (PLWH).
Effect of Therapy on Viral Burden and Immune Activation	Throughout	We wish to examine the effect of therapy on viral burden and/or immune activation in the immunoregulatory pathways observed in lymphocyte subsets in lmyphoid tissues (LT) versus peripheral blood mononuclear cells. For LT specimen, the analyses can be performed both on intact tissue sections and excised cells.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States