Tissue Biopsy and Imaging Studies in HIV-Infected Patients - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001471

Purpose

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.

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 may 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 a single time, or for patients starting a new therapy, biopsies could be performed before starting therapy, during therapy and possibly 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 Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.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 and volunteers) - Volunteers will have one intestinal biopsy procedure. Patients may have up to six intestinal biopsy procedures, each separated by at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A flexible tube (sigmoidoscope or colonoscope) 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.
Bronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special lens at the tip is inserted through the nose or mouth into the lungs, and the lining of the lung is sampled by washing the airways with small amounts of saline. The procedure is performed by a pulmonologist or critical care specialist, usually as an outpatient.

Condition
HIV Infection

Study Type:	Observational
Official Title:	Virologic and Immunologic Evaluation of Lymph Node, Tonsillar, and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid

Resource links provided by NLM:

MedlinePlus related topics: AIDS Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	535
Study Start Date:	November 1994
Estimated Primary Completion Date:	September 1997 (Final data collection date for primary outcome measure)

Detailed Description:

Examining tissues outside the bloodstream in HIV-infected patients and, for comparison, HIV uninfected volunteers, can provide insights into the pathogenesis of HIV infection. This protocol will provide a mechanism for sampling tissue sites. A total of 430 HIV-infected patients and 105 HIV uninfected volunteers will be enrolled in these studies. To assess changes in viral load and immunological parameters at sites outside the bloodstream during therapy of HIV-infected patients, sequential tonsillar, lymph node, or intestinal biopsies, or bronchoscopy with bronchoalveolar lavage will be undertaken during the course of therapy. In a small number of patients, sequential or simultaneous lymph node biopsies will be performed. In addition, uninfected healthy volunteers will be enrolled to have a tonsillar or intestinal biopsy or bronchoscopy with bronchoalveolar lavage; this will allow comparison of immunologic parameters in HIV-infected and uninfected tonsillar or intestinal tissues, or bronchoalveolar lavage fluid.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 75,000 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001471

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Pantaleo G, Graziosi C, Demarest JF, Butini L, Montroni M, Fox CH, Orenstein JM, Kotler DP, Fauci AS. HIV infection is active and progressive in lymphoid tissue during the clinically latent stage of disease. Nature. 1993 Mar 25;362(6418):355-8.

Pantaleo G, Graziosi C, Butini L, Pizzo PA, Schnittman SM, Kotler DP, Fauci AS. Lymphoid organs function as major reservoirs for human immunodeficiency virus. Proc Natl Acad Sci U S A. 1991 Nov 1;88(21):9838-42.

Fox CH, Tenner-Racz K, Racz P, Firpo A, Pizzo PA, Fauci AS. Lymphoid germinal centers are reservoirs of human immunodeficiency virus type 1 RNA. J Infect Dis. 1991 Dec;164(6):1051-7.

Study ID Numbers:	950027, 95-I-0027
Study First Received:	November 3, 1999
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00001471 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

AIDS
HIV
Retrovirus
Therapy
Response

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009