Search / Trial NCT00001471

Tissue Biopsy and Imaging Studies in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

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Trial Information

Current as of December 08, 2024

Recruiting

Keywords

Aids Hiv Retrovirus Therapy Response Natural History

ClinConnect Summary

This clinical trial is studying how HIV affects certain tissues in the body, specifically in the tonsils, lymph nodes, and large bowel, during treatment. By examining these tissues, researchers hope to learn more about changes in the amount of virus present and the behavior of specific white blood cells that are important for fighting infections. The study is open to HIV-infected patients and healthy volunteers aged 18 and older.

Eligible participants will go through a series of screenings, including medical history, physical exams, and blood tests. Those who join the study may undergo procedures like biopsies (which involve taking small samples of tissue) and tests to check their lung health. For patients, this might mean having several biopsies over time, while healthy volunteers typically have fewer. It's important to know that participants will need to meet certain health criteria to ensure their safety during these procedures. Overall, this study aims to deepen our understanding of HIV and improve future treatments.

Gender

ALL

Eligibility criteria

  • * 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 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:
  • • 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 Officials

Joseph A Kovacs, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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