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Home > "T" Clinical Trials Conditions > Tissue Biopsy and Imaging Studies in HIV-Infected Patients  Tissue Biopsy and Imaging Studies in HIV-Infected Patients
Tissue Biopsy and Imaging Studies in HIV-Infected Patients
For Condition: Healthy,HIV Infection
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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 Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.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.
Details: 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 rectal biopsies will be undertaken during the course of therapy. Up to 50 HIV-infected patients, most of whom will be participating in ongoing protocols, will be enrolled. In a small number of patients, sequential or simultaneous lymph node biopsies will be performed. In addition, up to 15 uninfected healthy volunteers will be enrolled to have a tonsillar biopsy; this will allow comparison of immunologic parameters in HIV-infected and uninfected tonsillar tissues. 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA FOR ALL VOLUNTEERS: Greater than 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 rectal 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 HIV POSITIVE VOLUNTEERS: HIV infection must be confirmed by ELISA and western blot. FOR HIV-NEGATIVE VOLUNTEERS: No underlying significant medical problem, especially an immunodeficiency or autoimmune disease, or an underlying problem requiring immunosuppressive therapy. 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-NEGATIVE VOLUNTEERS 1. HIV seropositivity 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 HIV POSITIVE VOLUNTEERS FOR RECTAL BIOPSIES: Significant heart valve abnormalities. FOR ALL FEMALE VOLUNTEERS UNDERGOING CT OR MRI SCANS: Pregnancy.
Total Enrollment: 265
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 950027; 95-I-0027
Study Start Date: November 21, 1994
Record last reviewed: October 9, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001471
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4. Cause of Pigment Dispersion Syndrome
5. Comparison of Externally and Self-Initiated Movements
Related Studies:
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Tissue Biopsy and Imaging Studies in HIV-Infected Patients
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