A Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety