Tissue Biopsy and Imaging Studies in HIV-Infected Patients
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| ClinicalTrials.gov Identifier: NCT00001471 |
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Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : September 12, 2018
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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 Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.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 or disease |
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| HIV Healthy Volunteers |
| Study Type : | Observational |
| Estimated Enrollment : | 635 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Virologic and Immunologic Evaluation of Lymph Node, Tonsillar, and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid |
| Study Start Date : | November 22, 1994 |
- Obtain lymphoid tissue by tonsillar, lymph node, or intestinal biopsies, or BAL fluid in patients with HIV, ICL, and healthy volunteers to evaluate for viral burden, lymphocyte subsets, and cytokine production. [ Time Frame: Each procedure visit where tissue is obtained ]
- Study clinically appropriate markers of inflammation [ Time Frame: Study visits where tissue and or bloodwork is obtained. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
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 BAL:
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.
In addition to the above:
FOR HIV POSITIVE VOLUNTEERS:
HIV infection must be confirmed by ELISA and western blot or dot blot. For patients with acute HIV infection and negative HIV serology, plasma HIV viral load greater than 10,000 copies/ml.
FOR HEALTHY VOLUNTEERS:
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 or dot blot.
FOR ICL PATIENTS:
Patients must meet the definition of ICL according to the CDC criteria: documented absolute CD4 T lymphocyte count of less than 300 cells per cubic millimeter or of less than 20 percent of total T cells on more than one occasion usually two to three months apart, without evidence of HIV infection or any defined immunodeficiency or therapy associated with depressed levels of CD4 T cells.
Absence of HIV infection as confirmed by negative ELISA and, if indicated, western blot or dot 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 OR ICL 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 BAL:
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001471
| Contact: Cheryl L. Chairez | (301) 496-3840 | chairezc@mail.nih.gov | |
| Contact: Joseph A Kovacs, M.D. | (301) 496-9907 | jkovacs@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov | |
| Principal Investigator: | Joseph A Kovacs, M.D. | National Institutes of Health Clinical Center (CC) |
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001471 History of Changes |
| Other Study ID Numbers: |
950027 95-I-0027 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | September 12, 2018 |
| Last Verified: | September 6, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
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AIDS HIV Retrovirus Therapy Response |