Search / Trial NCT00000986

The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex

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

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Recombinant Proteins Interleukin 2 Drug Interactions Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS. IL-2 is a substance found naturally in the body that boosts the body's immune response to invading organisms and tumor cells. These two drugs, when administered together, may have a mutually helpful effect in treating AIDS patients, but before this effect can be studied, it is important to understand the proper dose and any side effects that may occur when these drugs are used together. The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will inte...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Acetaminophen under the supervision of a study physician.
  • Prior Medication:
  • Required for at least 6 weeks prior to study entry:
  • Zidovudine at a dose of at least 300 mg/day.
  • Allowed:
  • Aerosolized pentamidine prior to combination therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • Currently receiving zidovudine (AZT) at a dose of at least 300 mg/day and have received the drug for at least 6 weeks.
  • Have a life expectancy of = or > 4 months.
  • Available for the duration of the study and for follow-up visits.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions will be excluded:
  • Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy.
  • A fever > 101 degrees F within the past 10 days.
  • Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders.
  • Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume < 75 percent).
  • Kaposi's sarcoma or other AIDS related malignancy.
  • Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months.
  • Concurrent Medication:
  • Excluded:
  • Cardiac medications.
  • Glucocorticosteroids.
  • Probenecid.
  • Acetylsalicylic acid.
  • Trimethoprim / sulfamethoxazole.
  • Acyclovir.
  • Allopurinol.
  • Drugs causing anemia, neutropenia, or nephrotoxicity.
  • Aerosolized pentamidine during combination therapy.
  • Nonsteroidal anti-inflammatory drugs by patients with thrombocytopenia (<75000 platelets/mm3).
  • Acetaminophen except under supervision of a study physician.
  • Patients with the following conditions will be excluded:
  • Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy.
  • A fever > 101 degrees F within the past 10 days.
  • Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders.
  • Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume < 75 percent).
  • Kaposi's sarcoma or other AIDS related malignancy.
  • Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Any antiretroviral drug, except zidovudine (AZT).
  • Excluded within 12 weeks of study entry:
  • Immunotherapy, including interleukins, interferons, tumor necrosis factor.
  • Other cytokines.
  • Biologic response modifiers.
  • Monoclonal antibodies.
  • BCG vaccines.
  • Active drug or alcohol abuse.

Attachments

readout_NCT00000986_2024-07-23.pdf

4.5 MB

NCT00000986_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

Pittsburgh, Pennsylvania, 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

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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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