Search / Trial NCT00000909

A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Interleukin 2 Dose Response Relationship, Drug Cd4 Lymphocyte Count Rna, Viral

Description

Previous studies have shown that interleukin-2, when given under the skin, results in CD4+ cell count increases, and may impact upon disease progression. A Phase III trial is the next step in the development of these efficacy trials. One question, however, has not been addressed in previous IL-2 studies: whether it is both safe and reasonable to allow prospective IL-2 recipients the autonomy of choosing whether or not to take antiretrovirals in addition to their cytokine therapy. This trial addresses that concern. In this open-label study, 36 patients are randomized to 1 of 3 treatment gro...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Have had at least one CD4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry.
  • Are at least 18 years old.
  • Agree to abstinence or use of effective methods of birth control 1 month before and during the study.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have a history of a potentially life-threatening autoimmune or inflammatory disease.
  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
  • Have a history of an AIDS-defining illness.
  • Have a history of cancer, other than Kaposi's sarcoma.
  • Have ever taken IL-2 or any antiretroviral medications.
  • Are pregnant.
  • Are taking certain medications, including anti-seizure medications.

Attachments

readout_NCT00000909_2024-06-14.pdf

4.5 MB

NCT00000909_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

London, , United Kingdom

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
41
4 stars
6
3 stars
2
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0
1 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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