Recruiting

Leukapheresis

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00029445

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

HIV

Study ID

NCT00029445

Start date

Aug 9, 2001

Status verified date

Jul 28, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

1. Adult (18 years-old or older)
2. 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.
3. Willingness to give informed consent for the storage of blood or tissue samples and HLA testing

AND at least one of the following:

  • An HIV-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:

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 contraindication to the apheresis procedure or research blood draw.
3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • 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... [ Time Frame: Ongoing ]
  • Perform genetic studies to characterize immune-related susceptibility/protective genes and compare these between patients groups and within families. [ Time Frame: Ongoing ]
  • Identify patients with broadly neutralizing sera and characterize their HIV-specific B cell responses [ Time Frame: Ongoing ]
  • Identification of the cause and effect relationships between viremia and putative immune correlates of control of HIV replication [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 1, 2026

Last verified

Jul 28, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-01.