Viral Load in Blood and Lymph Tissues in People Living With HIV
Recruiting · NCT00001316 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- HIV status must be documented by a licensed ELISA and confirmed either by Western 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 of positive lupus anticoagulant in a participant with no prior history of abnormal 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 is considered 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 accessible location.
- Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening
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 than minimal Kaposi's sarcoma.
- No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. 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 as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States