Tissue Biopsy and Imaging Studies in HIV-Infected Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/20/2019 |
| Start Date: | November 22, 1994 |
| Contact: | Cheryl L. Chairez |
| Email: | chairezc@mail.nih.gov |
| Phone: | (301) 496-3840 |
Virologic and Immunologic Evaluation of Lymph Node, Tonsillar, and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid
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withdrawn through a special needle injected into the site.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.
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.
Examining tissues outside the bloodstream in HIV-infected patients, patients with Idiopathic
CD4 lymphopenia (ICL) and, for comparison, HIV-uninfected healthy volunteers (hereafter
referred to as healthy volunteers), can provide insights into the pathogenesis of HIV
infection and ICL. This protocol will provide a mechanism for sampling tissue sites. A total
of 430 HIV-infected patients, 100 ICL patients and 105 healthy 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 (BAL) 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 BAL; this will allow
comparison of immunologic parameters in HIVinfected and uninfected tonsillar or intestinal
tissues, or BAL fluid. Finally, ICL patients may have tissue sampling to assess lymphocyte
distribution and possible function in tissues to better understand the pathogenesis of their
lymphopenia. Sequential or simultaneous tissue sampling may occur and longitudinal samples
may also be obtained to assess stability in tissue compartments or effect of possible
immunomodulatory treatments.
CD4 lymphopenia (ICL) and, for comparison, HIV-uninfected healthy volunteers (hereafter
referred to as healthy volunteers), can provide insights into the pathogenesis of HIV
infection and ICL. This protocol will provide a mechanism for sampling tissue sites. A total
of 430 HIV-infected patients, 100 ICL patients and 105 healthy 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 (BAL) 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 BAL; this will allow
comparison of immunologic parameters in HIVinfected and uninfected tonsillar or intestinal
tissues, or BAL fluid. Finally, ICL patients may have tissue sampling to assess lymphocyte
distribution and possible function in tissues to better understand the pathogenesis of their
lymphopenia. Sequential or simultaneous tissue sampling may occur and longitudinal samples
may also be obtained to assess stability in tissue compartments or effect of possible
immunomodulatory treatments.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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