Collecting blood components from HIV-infected patients for immune system research

Evaluation of Viral Factors and Immune Parameters to Study HIV-Specific Immunity

This study is collecting blood samples from people with HIV, especially those who manage the virus without medication, to see how their immune systems work compared to those who don't, and it also includes their family members to look at genetic factors.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00029445 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect white blood cells and plasma from HIV-infected patients, particularly focusing on long-term non-progressors who can control HIV without antiretroviral therapy. The research will investigate the role of specific HLA genes in the immune response to HIV by comparing individuals who control the virus with those who experience disease progression. Participants will undergo apheresis, a procedure that allows for the collection of larger quantities of blood components, to facilitate this research. The study also includes family members of participants to explore genetic factors related to immune control of HIV.

Who should consider this trial

Good fit: Ideal candidates include HIV-infected adults aged 18 and older with specific HLA types (B*57+, B*27+, A*01+) or those categorized as long-term non-progressors.

Not a fit: Patients who are pregnant or have severe health conditions that contraindicate apheresis may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to new insights into how the immune system controls HIV, potentially informing future treatments or preventive strategies.

How similar studies have performed: While this study builds on previous research into immune responses to HIV, the specific focus on long-term non-progressors and genetic factors is a novel approach.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel C Rogan, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rosemary McConnell, R.N.

Conditions: HIV, Natural History, Long-term nonprogressors, HLA B*5701, Apheresis, HIV Infection