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

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Trial Information

Current as of June 13, 2024

Terminated

Keywords

Hiv Infection Lymphocyte Turnover

Description

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 c...

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.

Attachments

readout_NCT00001651_2024-06-13.pdf

4.5 MB

NCT00001651_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Day 2, 5 (end of [6,6-2H2]-glucose infusion), 6, 8, 12, 16, 20, and 28. After day 28, visits will occur monthly through 6 months, then no more often than every 3 months through 2 years.

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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