Protocol Number: 81-I-0164

Title:

Apheresis Procedures to Obtain Plasma or Lymphocytes for In Vitro Studies

Number:

81-I-0164

Summary:

This study will collect blood plasma and white blood cells from individuals using a procedure called apheresis. Apheresis is a method of collecting larger quantities of certain blood components that can safely be collected through a simple blood draw. The blood components will be used in laboratory research studies.

Patients 18 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study. Relatives of patients and normal healthy volunteers will also be enrolled.

Individuals will undergo one of the following two apheresis procedures:

- Automated pheresis - Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma (liquid part of the blood) and white cells are extracted, and the red cells are re-infused into the donor through the same needle or 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.

- Manual pheresis - One unit (1 pint) of blood is drawn through a needle placed in an arm vein, similar to donating a pint of whole blood. The red blood cells, with or without plasma, are separated from the rest of the blood and returned to the donor through the same needle. Manual pheresis will be done only when a person's estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine. An adult small in size or markedly anemic, for example, may fall into this category.

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. Some of the blood may be used to screen for different types of viral liver infections, such as hepatitis A, B, C, D, E, F, or G.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

18 years of age or older

Adequate venous access

Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer

Adequate blood counts (HIV positive volunteers and volunteers with vasculitis or other inflammatory diseases: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 50,000; HIV negative normal healthy volunteers: hemoglobin greater than or equal to 12.5 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000)

Willing and able to provide written informed consent, comply with study requirements and procedures, and comply with clinic policies (including stored samples, hepatitis screening, and genetic testing including HLA testing)

EXCLUSION CRITERIA:

Pregnant and/or breast-feeding

Currently abusing alcohol or other drugs

Any medical condition for which the PI feels apheresis might be contraindicated

Special Instructions:

Telephone Marie Angeline Planta, RN, at (301) 435-7630 or 1-800-772-5464 X57630 and leave a message with your name, telephone number, and name of the study in which you wish to participate (apheresis).

Initial visit includes having your blood drawn and physical exam (approximately 90 minutes). If eligible, you will be notified and an appointment for apheresis will be scheduled. Participants will receive monetary compensation for the apheresis procedure.

Keywords:

Plasmapheresis

Leukapheresis

Lymphocytes

Apheresis

Recruitment Keyword(s):

None

Condition(s):

Blood Component Removal

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Malaspina A, et al. Deleterious effect of HIV-1 plasma viremia on B cell costimulatory function. J Immunol. 2003 Jun 15;170(12):5965-72.

Moir S, et al. Perturbations in B cell responsiveness to CD4+ T cell help in HIV-infected individuals. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6057-62. Epub 2003 May 01.

Migueles SA, et al. HIV-specific CD8+ T cell proliferation is coupled to perforin expression and is maintained in nonprogressors. Nat Immunol. 2002 Nov;3(11):1061-8. Epub 2002 Oct 07.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008