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

ConditionHIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

An HIV-seropositive participant categorized as an LTNP as defined by clinical and laboratory criteria, regardless of HLA class I type.

Disqualifiers

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.

Trial population

Individuals identified as having innate control over the HIV virus

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 3 trial groups
Group A: Family members
Group B: HIV infection with one of the following HLA types: B*27+, B*35+,B*44+, B*57+, B*58+, and/or A*02.
Group C: Long term nonprogressors

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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