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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 310 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Eligibility criteria expanded, about 18 words

    Show what changed: 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 pr [...] 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 [...] [...]

  4. Minor

    8 amendments

    8 re-verifications since 2026-06-27, no change to tracked fields

    v300-v307

  5. Minor

    Eligibility criteria shortened, about 32 words

    Show what changed: Eligibility criteria
    [...] tory values: Absolute neutrophil count of greater than 1000/mm3.mm^3 PT, PTT, within normal limits, (unless PTT is elevated in presence of positive lupus antic [...] abnormal bleeding). Adequate blood counts (PLWH: hemoglobin greater than or equal to>= 9.0 g/dL, HCT greater than or equal to>= 28%, platelets greater than or equal to>= 75,000; participants without HIV: hemoglobin greater than or equal to >=11.2 g/dL, HCT greater than or equal to >=34.1%, platelets greater than or equal to >=150,000). Blood pressure less than or equal to <=180/100; pulse rate 50-100, unless a lower pulse rate is conside [...] [...]

    Study Status, Eligibilityv299

Show 38 earlier versions

  1. Minor

    35 amendments

    35 re-verifications since 2025-04-18, no change to tracked fields

    v264-v298

  2. Notable

    Primary endpoints revised (3)

    Study title expanded, about 2 words

    Show what changed: Primary endpoints
    HIV-specificEffect B-Cellof Therapy on Viral Burden and T-cellImmune responsesActivation
    Show what changed: Study title
    Viral Load in Blood and Lymph Tissues ofin People Living With HIV-Infected Individuals

    Study Identification, Study Status, Study Description, Outcome Measures, Eligibilityv263

  3. Minor

    2 amendments

    2 re-verifications since 2025-02-21, no change to tracked fields

    v261-v262

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • 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 HIV
Enrollment 400 participants
Start Date
Updated on ClinicalTrials.gov