Search / Trial NCT00001354

Interleukin-2 Therapy for HIV Infection - Supplemental Procedures

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

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Aids Immunotherapy Cd4 Cells Immunomodulator Cytokines

Description

This study is designed as a randomized, open label trial to evaluate the effect of interleukin-2 (IL-2) on CD4 counts in patients with HIV infection and CD4 counts above 200 cells/mm(3). 60 patients will receive either antiretroviral therapy or antiretroviral therapy plus IL-2 administered by continuous infusion at a dose of 18 million international units (IU)/day for 5 days every two months for 1 year. Patients will be seen at the NIH every 4 weeks, at which time immune parameters, including CD4 number and percent, will be determined.

Gender

All

Eligibility criteria

  • Patients must have documented HIV infection (ELISA and Western blot positive).
  • Patients must be 18 years or older.
  • Patients must have CD4 count greater than 200 cells/mm(3).
  • Patients must have clinical laboratory values Grade 0 or 1.
  • Patients must not have therapy with corticosteroids, chemotherapy, or experimental therapy in the prior 4 weeks.
  • Patients must have a negative urine pregnancy test (women of childbearing potential).
  • Patients with prior IL-2 therapy will be excluded.
  • Patients with malignancy other than Kaposi sarcoma will be excluded. Patients with Kaposi sarcoma are eligible, but must not have received systemic therapy for KS within 4 weeks prior to study entry.
  • Patients with history of prior AIDS-defining opportunistic infection will be excluded.
  • Patients with active substance abuse which may affect patient safety or compliance will be excluded.
  • Patients exhibiting psychiatric disturbance or illness, which in the assessment of the protocol team may affect patient safety or compliance will be excluded.
  • Patients with significant cardiac, pulmonary, thyroid, kidney, rheumatologic, or CNS disease will be excluded.
  • Patients with hypertension requiring anti-hypersensitive therapy will be excluded.
  • Pregnant or lactating patients or patients of childbearing potential, will be excluded, unless they use effective contraception.
  • Patients unwillingness to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV seropositivity and the risk of transmission of HIV infection will be cause for exclusion.

Attachments

readout_NCT00001354_2024-06-14.pdf

4.5 MB

NCT00001354_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

Not reported

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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