Protocol Number: 02-I-0066

Title:

Studies of Specific Immune Responses in Human Peripheral Blood Cells in HIV-Infected and HIV-Uninfected Volunteers

Number:

02-I-0066

Summary:

This study will explore the responses of the immune system to HIV infection and changes in these responses over time.

Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study.

Participants will have a yearly medical examination, including blood tests to measure cell counts, evaluate kidney and liver function, and other lab tests as medically indicated. Women will have a blood or urine pregnancy test. Blood will be drawn from a needle in an arm vein one or more times during the course of the study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. The blood may be used for the following tests:

- Hepatitis and other viral screening-This may include screening for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus (related to the herpes virus); and for varicella zoster virus (responsible for chicken pox in children and shingles in adults).

- Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or chemical changes) or deletions (missing pieces) that affect substances involved in the body's ability to mount an inflammatory immune response. Alterations in the genes for some of these substances have been shown to influence HIV infection.

- HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is necessary in order to do certain research studies. Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems. HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions.

Some blood collected in this study may be stored for future research. It will be labeled without identifying information.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Willing to be tested for HIV.

Note: Subjects known to be HIV-infected will routinely have results of plasma HIV RNA obtained at or within 90 days of the enrollment visit recorded; volunteers believed to be HIV uninfected will usually have HIV ELISA (Western blot if needed) and/or HIV RNA within 28 days of the enrollment visit recorded. Test results do not have to be available before proceeding with enrollment. Consent to be tested is required, but the testing itself does not have to be completed if not needed by the research lab as subjects are eligible regardless of HIV status.

2. Age: 18 years of age or older.

3. Ability to provide informed consent

EXCLUSION CRITERIA:

1. Refusal to consent to follow study site policy on partner notification (if newly diagnosed as HIV-positive while participating in this study).

2. Refusal to permit research blood specimens to be stored (frozen) for potential future studies.

3. Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as coagulopathy or inadequate venous access).

4. Women known to be pregnant

Special Instructions: Currently Not Provided

Keywords:

T Cell

B Cell

Flow Cytometry

Cell-Mediated Immunity

Thymus

HIV

Immunity

Lymphocytes

Monocytes

Recruitment Keywords:

HIV

Healthy Volunteer

HV

Normal Control

Conditions:

Healthy

HIV Infection

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

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

Citations:

Betts MR, Casazza JP, Patterson BA, Waldrop S, Trigona W, Fu TM, Kern F, Picker LJ, Koup RA. Putative immunodominant human immunodeficiency virus-specific CD8(+) T-cell responses cannot be predicted by major histocompatibility complex class I haplotype. J Virol. 2000 Oct;74(19):9144-51.

PMID: 10982361

Allen TM, O'Connor DH, Jing P, Dzuris JL, Mothe BR, Vogel TU, Dunphy E, Liebl ME, Emerson C, Wilson N, Kunstman KJ, Wang X, Allison DB, Hughes AL, Desrosiers RC, Altman JD, Wolinsky SM, Sette A, Watkins DI. Tat-specific cytotoxic T lymphocytes select for SIV escape variants during resolution of primary viraemia. Nature. 2000 Sep 21;407(6802):386-90. PMID: 11014195

Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. PMID: 8207839

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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