Protocol Details

A Study of Viral Burden in Peripheral Blood versus Lymphoid and Bone Marrow Tissue in People living with HIV

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	92-I-0125
Sponsoring Institute	National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Keywords	Lymph Node; Polymerase Chain Reaction (PCR); In Situ Hybridization; AIDS; Excisional Biopsy; Natural History
Recruitment Keyword(s)	None
Condition(s)	HIV
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Allergy and Infectious Diseases

Our laboratory has previously demonstrated that lymph nodes are a major reservoir for human immunodeficiency virus (HIV) and a major site of active virus replication in infected individuals. There is at least a 10 fold greater viral burden per given number of CD4+ T lymphocytes obtained from the lymph nodes versus the peripheral blood in the same infected individual. These data have been accumulated predominantly in individuals with progressive generalized lymphadenopathy (CDC Class A1 and A2). It is unclear at present whether this pattern holds true for all categories of HIV infected individuals. We have proposed that the seeding of lymph nodes by HIV early in the course of HIV infection and the persistent production of virus in lymph nodes throughout the course of infection are major factors in the pathogenesis of HIV in virtually all infected individuals. In addition, it is likely that the selective perturbations of various T cell subsets (i.e., V-B classes of CD4+T cells) that have been observed in peripheral blood are much more dramatic in the lymph node given the greater viral burden in the lymph node compared to the peripheral blood. In order to investigate this hypothesis, it is essential that we study simultaneously lymph nodes and peripheral blood from the same individuals and that we study different individuals at various stages of disease from early in the course of infection (CDC Class A) to advanced disease (CDC Class B and C). If, as we suspect, there is active virus replication in the lymph node early in the course of infection, even at a time when there is little virus burden or active replication in the peripheral blood, this would justify anti-retroviral therapy at the earliest possible time in the course of infection. In addition, in certain patients who are about to initiate treatment with an anti-retroviral agent such as zidovudine or didanosine through their private physician, it would be important to know whether treatment actually reduces the viral burden and virus replication in lymph nodes. The effect of therapy on viral burden and replication will be compared in the lymph node versus peripheral blood mononuclear cells and both of these parameters will be compared with the level of plasma viremia.

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Eligibility

INCLUSION CRITERIA:

1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.

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 (unless PTT is elevated in presence of positive lupus anticoagulant in a participant with no prior history of abnormal bleeding).

c) Adequate blood counts (PLWH: 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; participants without HIV: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, 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 participant.

5. Participants who do not have HIV will qualify as control participants.

6. Participants must have a clinically palpable lymph node in an easily accessible location.

7. Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening

EXCLUSION CRITERIA:

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

2. Currently abusing alcohol or other drugs, including narcotics or cocaine.

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

4. No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.

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

6. Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Susan Moir, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 6A02 10 Center Drive Bethesda, Maryland 20892 (301) 402-4559 sm221a@nih.gov	Catherine A. Seamon, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 8C404 10 Center Drive Bethesda, Maryland 20892 (301) 402-3481 cseamon@cc.nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT00001316

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