HIVNCT00001471
Tissue Biopsy and Imaging Studies in HIV-Infected Patients
An observational study of HIV and ICL, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV, ICL, Healthy Volunteers
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 1994to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients already seen in our outpatient clinic, as well as individuals recruited from outside clinics.
Who may be able to join
- 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.
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- 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.
Who cannot join
- FOR ALL VOLUNTEERS UNDERGOING BIOPSIES:
- Platelet count less than 75,000 platelets/mm(3).
- PT or PTT prolonged by greater than 2 seconds unless patient has documented lupus anticoagulant/anti-phospholipid syndrome, which is not associated with an increased bleeding risk
- Known underlying bleeding disorder.
- Pregnancy.
- FOR HIV-POSITIVE OR ICL VOLUNTEERS FOR LYMPH NODE BIOPSIES:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- HIV, ICL, Healthy Volunteers
- Keywords
- AIDS, HIV, Retrovirus, Therapy, Response, Natural History
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers | |
| HIV-infected | HIV-infected individuals | |
| ICL | Idiopathic CD4 lymphopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Evaluate for viral burden, lymphocyte subsets, and cytokine production.
Measured: Each procedure visit where tissue is obtained.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start30 Nov 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001471
- Sponsor's protocol ID
- 950027
- Other IDs
- 95-I-0027
- Status last verified
- 26 Mar 2026
- First submitted
- 3 Nov 1999
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng M, Southern PJ, Reilly CS, Beilman GJ, Chipman JG, Schacker TW, Haase AT. Lymphoid tissue damage in HIV-1 infection depletes naive T cells and limits T cell reconstitution after antiretroviral therapy. PLoS Pathog. 2012 Jan;8(1):e1002437. doi: 10.1371/journal.ppat.1002437. Epub 2012 Jan 5.
PubMed 22241988Brenchley JM, Schacker TW, Ruff LE, Price DA, Taylor JH, Beilman GJ, Nguyen PL, Khoruts A, Larson M, Haase AT, Douek DC. CD4+ T cell depletion during all stages of HIV disease occurs predominantly in the gastrointestinal tract. J Exp Med. 2004 Sep 20;200(6):749-59. doi: 10.1084/jem.20040874. Epub 2004 Sep 13.
PubMed 15365096Mavigner M, Cazabat M, Dubois M, L'Faqihi FE, Requena M, Pasquier C, Klopp P, Amar J, Alric L, Barange K, Vinel JP, Marchou B, Massip P, Izopet J, Delobel P. Altered CD4+ T cell homing to the gut impairs mucosal immune reconstitution in treated HIV-infected individuals. J Clin Invest. 2012 Jan;122(1):62-9. doi: 10.1172/JCI59011. Epub 2011 Dec 12.
PubMed 22156200
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic and Immunologic Evaluation of Lymph Node, Tonsillar and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid
- ClinicalTrials.gov ID
- NCT00001471
- Acronym / sponsor ID
- 950027
- Conditions
- HIV, ICL, Healthy Volunteers
- Keywords
- AIDS, HIV, Retrovirus, Therapy, Response, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 30 Nov 1994 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
| HIV-infected | – | –HIV-infected individuals |
| ICL | – | –Idiopathic CD4 lymphopenia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients already seen in our outpatient clinic, as well as individuals recruited from outside clinics.
Key inclusion criteria (21 listed)
- 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.
- No medical contraindication to tonsillar, lymph node, or intestinal biopsy.
Key exclusion criteria (17 listed)
- Platelet count less than 75,000 platelets/mm(3).
- PT or PTT prolonged by greater than 2 seconds unless patient has documented lupus anticoagulant/anti-phospholipid syndrome, which is not associated with an increased bleeding risk
- Known underlying bleeding disorder.
- Pregnancy.
- Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Evaluate for viral burden, lymphocyte subsets, and cytokine production.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 22241988Zeng M, Southern PJ, Reilly CS, Beilman GJ, Chipman JG, Schacker TW, Haase AT. Lymphoid tissue damage in HIV-1 infection depletes naive T cells and limits T cell reconstitution after antiretroviral therapy. PLoS Pathog. 2012 Jan;8(1):e1002437. doi: 10.1371/journal.ppat.1002437. Epub 2012 Jan 5.
- Background: PubMed 15365096Brenchley JM, Schacker TW, Ruff LE, Price DA, Taylor JH, Beilman GJ, Nguyen PL, Khoruts A, Larson M, Haase AT, Douek DC. CD4+ T cell depletion during all stages of HIV disease occurs predominantly in the gastrointestinal tract. J Exp Med. 2004 Sep 20;200(6):749-59. doi: 10.1084/jem.20040874. Epub 2004 Sep 13.
- Background: PubMed 22156200Mavigner M, Cazabat M, Dubois M, L'Faqihi FE, Requena M, Pasquier C, Klopp P, Amar J, Alric L, Barange K, Vinel JP, Marchou B, Massip P, Izopet J, Delobel P. Altered CD4+ T cell homing to the gut impairs mucosal immune reconstitution in treated HIV-infected individuals. J Clin Invest. 2012 Jan;122(1):62-9. doi: 10.1172/JCI59011. Epub 2011 Dec 12.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Kovacs, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and ICL, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001471, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.