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Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 458 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Notable

    Primary endpoints: details revised at 1 of 4 entries

    Eligibility criteria expanded, about 10 words; Study description expanded, about 3 words

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: 1. Adult (18 years-old or older) 2. Eligibility to undergo apheresis procedures; or, for partici [...] remain within safety guidelines established by NIH policy. 3. Willingness to give informed consent for the storage of bloo [...] samples and HLA testing AND at least one of the following: * An HIV-seropositive participant categorized as an LTNP as de [...] al and laboratory criteria, regardless of HLA class I type. * HIV-seropositive progressors * Persons who are seronegative for HIV but are family members [...] s exhibiting immunologic control of HIV EXCLUSION CRITERIA: 1. Pregnant 2. Cardiovas [...] [...]
    Show what changed: Study description
    [...] l replication, we aim to study three groups of individuals: 1. People living with HIV who appear to control HIV primarily t [...] specific cellular immunity (long-term nonprogressors/LTNP); 2. People living with HIV who have broadly cross-neutralizing antibody activity against HIV; and 3. the family members of participants exhibiting immunologic co [...]

  3. Minor

    7 amendments

    7 re-verifications since 2026-07-29, no change to tracked fields

    v450-v456

  4. Minor

    Enrollment increased: 400 → 500 participants

    Study Status, Study Designv449

  5. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v448

Show 39 earlier versions

  1. Minor

    Study description revised

    Show what changed: Study description
    [...] to study three groups of individuals: People living with HIV, who appear to control HIV primarily through virus-specific [...]

    Study Status, Study Descriptionv447

  2. Minor

    38 amendments

    38 re-verifications since 2025-05-03, no change to tracked fields

    v409-v446

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients. People living with HIV who are 18 years of age and older, documented or suspected long-term nonprogressors in generally good health may be eligible to screen for the study. Participants will undergo apheresis (a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw) if venous access is adequate once yearly. Some may be asked to return every six months. * Automated apheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine, separating the blood components. The white cells are extracted and the red cells, with or without plasma (liquid part of the blood), are re-infused into the donor through a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing. * Blood draw - a needle placed in an arm vein for large volume (approx 75ml) blood draw if veins considered inadequate for apheresis procedure. Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system.
Trial Details
NCT Number NCT00029445
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HIV
Enrollment 500 participants
Start Date
Updated on ClinicalTrials.gov