Search / Trial NCT00001651

Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients

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

Trial Information

Current as of December 08, 2024

Terminated

Keywords

Hiv Infection Lymphocyte Turnover

ClinConnect Summary

Understanding the rate of lymphocyte replication and destruction in HIV-infected patients, as well as the effects of therapy on lymphocyte replication should lead to a better understanding of the mechanisms behind the immunodeficiency induced by HIV. To examine this directly, up to 100 HIV-infected patients will receive up to 5 days of continuous infusions with \[6,6-(2)H(2)\]-glucose, a nonradioactive, stable isotope of glucose that is safe to administer. The deuterium is incorporated into DNA via metabolism of glucose to ribose and incorporation into nucleotides. The rate of incorporation...

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • FOR PATIENTS:
  • 18 years or older.
  • Able to provide informed consent and willing to comply with study requirements and clinic policies.
  • Negative urine pregnancy test (for women of childbearing potential).
  • Hemoglobin greater than 10 mg/dl.
  • Adequate venous access in the arms for blood drawing and 5 day infusions, and lymphapheresis
  • Willingness to allow stored samples to be used for future studies of HIV infection and/or immunological function, and willingness to have HLA typing performed. (For previously enrolled patients, patients would be requested, but not required, to provide permission to use stored samples in the future, and to permit HLA testing
  • FOR HIV POSITIVE PATIENTS:
  • Documented HIV infection (ELISA/Western blot positive or, for acute seroconverters, PCR positive).
  • FOR HIV NEGATIVE PATIENTS:
  • Negative ELISA/Western blot.
  • EXCLUSION CRITERIA:
  • Diabetes mellitus requiring drug therapy.
  • Active substance abuse or prior history of substance abuse which may interfere with protocol compliance.
  • Psychiatric illness or disturbance which, in the assessment of the protocol team, may affect patient safety or compliance.
  • Significant underlying cardiac, pulmonary, renal, gastrointestinal, rheumatologic or CNS disease as detectable on routine history, physical exam, or screening laboratory studies. Patients would be excluded if they had an acute or chronic underlying medical problem that in the judgment of the principal investigator could be exacerbated by participating in the protocol or that would make it difficult for them to comply with the protocol requirements.
  • Pregnancy or breast-feeding.

Trial Officials

Joseph A Kovacs, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

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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