Protocol Number: 95-I-0027

Title:

Virologic and Immunologic Evaluation of Lymph Node, Tonsillar, and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid

Number:

95-I-0027

Summary:

This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected patients to investigate changes in viral load and certain white blood cells during treatment. It will also use computed tomography (CT) to examine the thymus, a special type of lymphoid tissue that lies in the chest behind the breast bone.

Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a genetic test of immune system markers.

Participants will undergo the following procedures:

- Blood tests (patients and volunteers)

- Biopsies - The frequency of biopsies for given patients may vary, depending on their specific therapy. Typically, biopsies are done at least before starting therapy, during therapy and after completion of therapy.

- Tonsil biopsies (patients and volunteers) - Volunteers will have one tonsil biopsy. Patients will have no more than six tonsil biopsies, with no more than three in a 10-day period. The biopsy is done by an ear, nose and throat specialist as an outpatient procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of tissue are extracted.

- Lymph node biopsies (patients only) - Patients will have no more than four lymph node biopsies, performed no more frequently than once a month. The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is numbed with a local anesthetic, an incision is made and the tissue is removed. Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.

- Intestinal biopsies (patients only) - Patients may have up to six intestinal biopsies, each separated by at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A flexible tube (sigmoidoscope) with a light and special lens at the tip is inserted into the rectum and large bowel. Wire instruments passed through the tube are used to extract small tissue samples.

- Scans

- CT scans (patients and volunteers) - Patients may have no more than six scans, up to three within a 1-year period. Volunteers may have up to three scans, with no more than one every 6 months. CT uses ionizing radiation to produce 3-dimensional images of the thymus in small sections. For the procedure, the patient lies still for a short time on a table surrounded by the scanner.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA - ALL VOLUNTEERS:

Greater than or equal to 18 years old.

Ability to sign informed consent.

For women of child-bearing potential, negative result on a serum or urine pregnancy test within 1 week prior to the procedure.

Willingness to allow storage of blood or biopsy samples for possible future use to study HIV/AIDS, related diseases or the immune system; willingness to permit HLA testing.

FOR PATIENTS UNDERGOING BIOPSIES:

No medical contraindication to tonsillar, lymph node, or intestinal biopsy.

For tonsillar biopsy, presence of visible tonsillar tissue; for lymph node biopsy, palpable lymph nodes.

No aspirin or piroxicam (Feldene) for 10 days prior to the procedure; other non steroidal anti-inflammatory drugs (e.g. ibuprofen) must be discontinued the day prior to the procedure. Acetaminophen [Tylenol] is permitted at any time.

FOR PATIENTS UNDERGOING BRONCHOALVEOLAR LAVAGE:

Hematocrit greater than 27 percent, platelets greater than 50,000/ml.

Baseline pulse-oximetry recording of 94 percent or greater unless clinical indication for bronchoscopy.

No medical contraindication to bronchoscopy.

FOR HIV POSITIVE VOLUNTEERS: (In addition to the above)

HIV infection must be confirmed by ELISA and western blot. For patients with acute HIV infection and negative HIV serology, plasma HIV viral load greater than 10,000 copies/ml.

FOR HIV-NEGATIVE VOLUNTEERS: (In addition to the above)

No underlying significant medical problem, especially an immunodeficiency or autoimmune disease, or an underlying problem requiring immunosuppressive therapy.

Absence of HIV infection as confirmed by negative ELISA and, if indicated, western blot.

EXCLUSION CRITERIA:

FOR ALL VOLUNTEERS UNDERGOING BIOPSIES:

Platelet count less than 100,000 platelets/mm(3).

PT or PTT prolonged by greater than 2 seconds.

Known underlying bleeding disorder.

Pregnancy.

FOR HIV-POSITIVE VOLUNTEERS FOR LYMPH NODE BIOPSIES:

Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.

FOR ALL VOLUNTEERS FOR INTESTINAL BIOPSIES:

Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.

Significant heart valve abnormalities.

Presence of pacemaker, artificial joint or vascular surgery graft.

FOR ALL VOLUNTEERS FOR BRONCHOSCOPY:

Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.

Pregnancy.

Any medical condition for which the investigators believe bronchoscopy may be contraindicated.

Allergy to lidocaine.

History of asthma requiring therapy.

Special Instructions:

Protocol closed to enrollment of normal volunteers.

Keywords:

AIDS

HIV

Retrovirus

Therapy

Response

Recruitment Keyword(s):

None

Condition(s):

HIV Infection

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):

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

Lymphoid organs function as major reservoirs for human immunodeficiency virus

Lymphoid germinal centers are reservoirs of human immunodeficiency virus type 1 RNA

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