Protocol Number: 92-I-0125

Title:

Analysis of Peripheral Blood Versus Lymphoid Tissue in HIV-Infected Individuals and Normal Patients

Number:

92-I-0125

Summary:

This study will examine and compare lymph tissues and peripheral white blood cells in HIV-infected patients. Lymph nodes are a major site of viral accumulation and replication. Study of the effects of the virus on white cells from both peripheral blood and lymph nodes of the same individual may further understanding of the role of lymph nodes in the course of infection and immune destruction. Cells from uninfected normal volunteers will also be collected to serve as a control for experiments.

HIV-infected persons 18 years of age and older and normal healthy volunteers may be eligible for this study. Infected individuals at various stages of infection-from early in the course of infection to advanced disease- will be enrolled. Candidates will be screened with a physical examination and blood tests. Women will have a urine pregnancy test. Patients with AIDS dementia or with an AIDS-related cancer other than minimal Kaposi's sarcoma may not participate.

Participants will undergo the following procedures:

- Blood drawing - Blood samples will be collected through a needle in an arm vein. No more than 400 cc (less than a pint) of blood will be drawn during the study period

- Lymph node biopsy - A lymph node from the groin, armpit or neck will be removed for examination and testing. The biopsy will be done under local anesthesia and possibly with a sedative to minimize discomfort. HIV-infected patients may be asked to undergo a second biopsy 6 weeks to 12 months after the first one.

The findings of this study may have implications for treatment. If virus replication in the lymph nodes is found to occur early in the course of infection before large amounts of virus can be detected in peripheral blood, it may prove beneficial to start anti-viral therapy as early as possible.

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): None

Eligibility Criteria:

INCLUSION CRITERIA

1. HIV infection must be documented by a licensed ELISA and confirmed either by Western blot, positive HIV culture, positive HIV antigen, plasma viremia, or second antibody test positive by a method other than ELISA.

2. Aged 18 years or older.

3. Ability to give informed, written consent.

4. The following laboratory values:

a) Absolute neutrophil count of greater than 1000/mm3.

b) PT, PTT within normal limits.

c) Adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; HIV negative volunteers: hemoglobin greater than or equal to 12.0 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000).

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

5. CD4+T cell count of any level.

6. Patients may be receiving anti-retroviral therapy.

7. Patients may be receiving prophylaxis for opportunistic infections.

8. HIV negative individuals will qualify as control subjects.

EXCLUSION CRITERIA:

1. Women who are pregnant and/or breast-feeding.

2. Currently abusing alcohol or other drugs.

3. Patients with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.

4. Patients who have taken more than two 650 mg doses of aspirin less than one week prior to the date of biopsy.

5. Patients who have taken non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g. ibuprofen, naproxen, and similar drugs) within 24 hours prior to the date of biopsy.

6. Any medical condition for which the PI feels LN BX might be contraindicated.

Special Instructions: Currently Not Provided

Keywords:

Lymph Node

Polymerase Chain Reaction (PCR)

Viremia

In Situ Hybridization

AIDS

Excisional Biopsy

RNA/DNA

Recruitment Keywords:

None

Conditions:

HIV Infection

Viremia

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:

HIV infection is active and progressive in lymphoid tissue during the clinically latent stage of disease

Studies in human immunodeficiency virus-infected individuals who are long term non-progressors

Heterozygosity for a defective gene for CC chemokine receptor 5 is not the sole determinant for the immunologic and virologic phenotype of HIV-infected long term non-progressors

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/26/2004