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

NCT00029445 | Recruiting

• 2 other identifiers: 02008602-I-0086
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  Ongoing

• 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.

  Ongoing

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

  characterize HIV-specific neutralizing antibody activity

  Ongoing

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

  to understand HIV-specific immunity

  Ongoing

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals identified as having innate control over the HIV virus

You may qualify if:

• Adult (18 years-old or older)
• 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.
• 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

You may not qualify if:

• Pregnant
• 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.
• Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Daniel C Rogan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary McConnell, R.N.

CONTACT

(301) 312-1235; rosemary.mcconnell@nih.gov

Daniel C Rogan, M.D.

CONTACT

(301) 642-3852; daniel.rogan@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2002
• First Posted: January 14, 2002
• Study Start: August 9, 2001
• Last Updated: May 22, 2026

Record last verified: 2026-03-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)