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Recruiting NCT00001316

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

Conditions: HIV

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: Yes
Enrollment: 400
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Location: National Institutes of Health Clinical Center Bethesda Maryland

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 CRITERIA: 1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia. 2. Aged 18 years or older. 3. Ability to give informed, written consent. 4. The following laboratory values: 1. Absolute neutrophil count of greater than 1000/mm\^3 2. 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). 3. 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) 4. Blood pressure \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00001316). StuddyBuddy aggregates publicly available trial information.