|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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:
| Condition |
|---|
|
HIV Infection |
| Study Type: | Observational |
| Official Title: | Virologic and Immunologic Evaluation of Lymph Node, Tonsillar, and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid |
| 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) |
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 |
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| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| 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 |
|
AIDS HIV Retrovirus Therapy Response |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
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 |