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

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Minor Eligibility criteria expanded, about 18 words
  5. 8 versions Re-verified since Jun 27, 2026, no change to tracked fieldsv300-v307
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  1. Study Status, Eligibilityv299
  2. 35 versions Re-verified since Apr 18, 2025, no change to tracked fieldsv264-v298
  3. Study Identification, Study Status, Study Description, Outcome Measures, Eligibilityv263
  4. Re-verified, no change to tracked fieldsv262
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00001316
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)
HIV
Related terms Acquired Immunodeficiency Syndrome
Enrollment 400 participants
Start Date
Updated on ClinicalTrials.gov