NCT00001316Recruiting
Viral Load in Blood and Lymph Tissues in People Living With HIV
A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in People Living With HIV
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 3 Nov 1999
- Start date
- 26 Aug 1992
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- HIV
- NCT number
- NCT00001316
What you commit to
- Study type: Observational
- Planned participants: 400
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently abusing alcohol or other drugs including narcotics or cocaine
- No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.
- 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.
Other illness
- Participants with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.
- Any medical condition for which the PI feels LN BX might be contraindicated
Other
- Women who are pregnant and/or breast-feeding
Criteria the registry did not label
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.