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

• Status: Completed
• Trial end date: 1994-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the safety and tolerance of three different doses of recombinant human interleukin 2 (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just before beginning the IL-2 treatment.

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 interact with each other.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin; Interleukin-2; Zidovudine

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.