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NCT00001471 · ClinicalTrials.gov registry record
Tissue Biopsy and Imaging Studies in HIV-Infected Patients
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 386
- Enrollment target
NCT00001471: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001471 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 386 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001471 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 386 participants
- Enrollment target
Study 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. 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
Primary Outcome
Evaluate for viral burden, lymphocyte subsets, and cytokine production.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 1994-11-30 |
What the finished NCT00001471 record still lists
NCT00001471 is an observational study that tracks outcomes without assigning an intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00001471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001471 about?
NCT00001471 is a clinical study titled "Tissue Biopsy and Imaging Studies in HIV-Infected Patients". 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 ...
What is the current status of trial NCT00001471?
This trial is currently completed. The enrollment target is 386 participants. The study started on 1994-11-30.
Who is sponsoring clinical trial NCT00001471?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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