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

Phase

N/A

Condition

Hiv Infections

Hiv

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00001316

920125

92-I-0125

Ages 18-100
All Genders
Accepts Healthy Volunteers

Study 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....

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

HIV status must be documented by a licensed ELISA and confirmed either byWestern blot, or plasma viremia.
Aged 18 years or older.
Ability to give informed, written consent.
The following laboratory values:
Absolute neutrophil count of greater than 1000/mm^3
PT, PTT, within normal limits, (unless PTT is elevated in presence ofpositive lupus anticoagulant in a participant with no prior history ofabnormal bleeding).
Adequate blood counts (PLWH: hemoglobin >= 9.0 g/dL, HCT >= 28%, platelets >= 75,000; participants without HIV: hemoglobin >=11.2 g/dL, HCT >=34.1%,platelets >=150,000)
Blood pressure <=180/100; pulse rate 50-100, unless a lower pulse rate isconsidered normal for the participant
Participants who do not have HIV will qualify as control participants.
Participants must have a clinically palpable lymph node in an easily accessiblelocation.
Willingness to allow blood samples to be used for future studies of HIVinfection/pathogenesis, undergo genetic testing including HLA testing, andundergo hepatitis screening

Exclusion

EXCLUSION CRITERIA:

Women who are pregnant and/or breast-feeding
Currently abusing alcohol or other drugs including narcotics or cocaine
Participants with AIDS dementia or with an AIDS related malignancy other thanminimal Kaposi's sarcoma.
No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior toprocedure. Acetaminophen (Tylenol) is permitted at any time.
Any medical condition for which the PI feels LN BX might be contraindicated
Participants in which sedation is planned. Use of narcotics (other than asprescribed by a physician) or cocaine less than 1 week prior to the date of biopsywill be excluded.

Study Design

August 26, 1992

Study 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.

Connect with a study center

National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United States
Active - Recruiting

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