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Tissue Biopsy and Imaging Studies in HIV-Infected Patients
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
First Received: November 3, 1999   Last Updated: June 9, 2009   History of Changes
Sponsored by: 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. 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 Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.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.

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:


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

Estimated Enrollment: 535
Study Start Date: November 1994
Estimated Study Completion Date: September 1997
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 and for radiographically examining the thymus. A total of 430 HIV-infected patients and 115 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. Up to 280 HIV-infected patients, most of whom will be participating in ongoing protocols, will be enrolled in tissue sampling studies. In a small number of patients, sequential or simultaneous lymph node biopsies will be performed. In addition, up to 65 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.

To assess the role of the thymus in immunologic changes during therapy for HIV infection, up to 150 HIV-infected patients and 50 HIV uninfected volunteers will undergo one or more CT scans of thymic tissue.

  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 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.

  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
  More Information

Additional Information:
Publications:
Study ID Numbers: 950027, 95-I-0027
Study First Received: November 3, 1999
Last Updated: June 9, 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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

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 July 02, 2009