ClinicalTrials.gg
RecruitingNCT00029445Updated Oct 27, 2026

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

An observational study in HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

From the registry’s dates

  • Started Aug 2001; still recruiting 25 years 3 months later.
Updated Oct 15, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
500
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) — 10 open to participants now, 15 under way, 1 of them phase 3. HIV Infections · National Institute of Allergy and Infectious Diseases (NIAID).

Planned enrollment
44th of 136
500 · median 174
Started
2001
with 17 others
Observational
142 of 1,034
3 open now
Registered
614th of 1,034
by date

Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 44th largest by planned enrollment of the 136 observational ones that give a count, is one of 18 that started in 2001, is one of 142 observational ones, and was the 614th registered.

HIV Infections

4,735 studies on the registry are indexed under HIV Infections; 245 are open to participants now.

Browse HIV Infections studies →

Open to participants now

10 of the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 12 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Who these studies take

Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), or all of them as a file.
02

Study summary

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.

Read the detailed description

In an attempt to elucidate the mechanism(s) of immune-mediated restriction of HIV viral replication, we aim to study three groups of individuals:

  1. People living with HIV who appear to control HIV primarily through virus-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 control of HIV infection. Although most of our previous efforts have focused on investigating the virus-specific immune responses in a unique group of patients termed LTNP who control HIV by cellular immune-mediated mechanisms, more recently, another group of rare individuals who naturally develop broadly cross-neutralizing antibody activity against HIV isolates have also been identified in our laboratory. Passive transfer studies in nonhuman primates have demonstrated that neutralizing antibodies detectable in a subject at the time of challenge can protect from infection. We aim to recruit more of these participants in an effort to further characterize and compare their virus-specific cellular and humoral immune responses with those in individuals experiencing progressive infection. As we attain greater insight into differences between these participant groups, we hope to perform genetic studies that would enable us to more precisely identify susceptibility or protective genes, which could be potentially used to construct a familial pedigree. We anticipate that all of these findings will contribute to an enhanced understanding of the nature of effective HIVspecific humoral and cellular immunity, which will help focus future vaccine design efforts. For our studies, it will be necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is designed to conform to the requirements of the Apheresis Unit for donors to have leukapheresis or plasmapheresis procedures. In select participants, lymphocytes obtained from lymph node biopsy will also be studied.
03

Conditions studied

  • HIV

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Keywords

  • Natural History
  • Long-term nonprogressors
  • HLA B*5701
  • Apheresis
  • HIV Infection
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals identified as having innate control over the HIV virus

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult (18 years-old or older)

    1. Eligibility to undergo apheresis procedures; or, for participants who are unable to undergo apheresis, willingness to undergo blood draw for research purposes that remain within safety guidelines established by NIH policy.
    2. Willingness to give for the storage of blood or tissue samples and HLA testing

AND at least one of the following:

  • An -seropositive participant categorized as an LTNP as defined by clinical and laboratory criteria, regardless of HLA class I type.
  • HIV-seropositive progressors
  • Persons who are seronegative for HIV but are family members of seropositive participants exhibiting immunologic control of HIV

Exclusion criteria

EXCLUSION CRITERIA:

  1. Pregnant
  2. Cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, or any other condition that the Principal Investigator or Apheresis Unit staff considers a to the apheresis procedure or research blood draw.
  3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
500 participants (estimated)

Groups and cohorts

  • Family members

    Family members of individuals with innate control over HIV

  • HIV infection with one of the following HLA types: B*27+, B*35+,B*44+, B*57+, B*58+, and/or A*02.

    People living with HIV with specific HLA-types.

  • Long term nonprogressors

    Individuals with innate control over HIV

06

What researchers measure

Primary outcomes

  1. To further investigate differences in the virus-specific T cell-mediated responses between HIV-1-infected LTNP and patients with progressive disease who bear HLA class I alleles that have been associated with delayed disease progression and to c...

    deeper understanding of the components and correlates of an effective HLA class-I-restricted HIV-specific CD8+ T cell response

    Time frame: Ongoing

  2. Perform genetic studies to characterize immune-related susceptibility/protective genes and compare these between patients groups and within families.

    Availability of cells from family members of LTNP with or without putative response modifiers could help in defining the role of these genes in shaping the immune response to HIV.

    Time frame: Ongoing

  3. Identify patients with broadly neutralizing sera and characterize their HIV-specific B cell responses

    characterize HIV-specific neutralizing antibody activity

    Time frame: Ongoing

  4. Identification of the cause and effect relationships between viremia and putative immune correlates of control of HIV replication

    to understand HIV-specific immunity

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underline the results reported in the publication, after de-identification (text, tables, figures, and appendices)

Supporting information: Study protocol

Time frame: Beginning 9 months and ending 36 months following article publication

Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Analysis for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication.

09

Timeline

5 registry updates since Sep 25, 2026

Started Aug 2001 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2002
First posted
Jan 14, 2002
StartActual
Aug 9, 2001
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: removed j•••@niaid.nih.gov · •••7913. See the current contact
Oct 15, 2026
Show all 5 updates
  1. Oct 27, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 16, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 15, 2026
    Contact Study contact changed: removed j•••@niaid.nih.gov · •••7913. See the current contact
    + 1 other change: verification date
  5. Oct 13, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00029445
Responsible party
Sponsor
First posted
Jan 14, 2002
Start date
Aug 9, 2001
Last update
Oct 27, 2026

Study contacts

Daniel C Rogan, M.D.
Contact
daniel.rogan@nih.gov
(301) 642-3852
Daniel C Rogan, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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