Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

Four escalating doses of PEG IL-2 are studied. Patients are stratified by CD4 level. CD4 levels in Group A are 200 to 500 cells/mm3; in Group B - 1 to less than 200 cells/mm3. Further stratification is by p24 positive or negative, antiviral therapy for more or less than a year, and zidovudine (AZT) versus didanosine (ddI). The duration of PEG IL-2 treatment is a maximum of 28 weeks. This is an outpatient study; patients will be observed for four hours after the first dose of PEG IL-2 and for one hour after subsequent doses.

Inclusion criteria

Patients must have:

• HIV seropositivity by commercially available ELISA.
• Meet Disease Status criteria.

Exclusion criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Concurrent neoplasms other than basal cell carcinoma of the skin, in-situ carcinoma of the cervix or limited cutaneous Kaposi's sarcoma.
• Recently treated HIV-related lymphoma.
• Major organ allograft.
• Presence of space occupying central nervous system (CNS) lesions or other conditions which would be anticipated to cause cerebral edema.
• Renal compromise or use of drug therapy anticipated to lead to renal compromise.
• Active opportunistic infection requiring hospitalization or exclude medication.
• Requiring continual acyclovir for suppression of herpes infection.

Concurrent Medication:

Excluded:

• Acyclovir.
• Drug therapy anticipated to lead to renal compromise.

Patients with the following are excluded:

• Intolerance to zidovudine (AZT) at 300 mg/day divided q8h or didanosine (ddI) at 7 mg/kg/day given twice a day.
• History of HIV-related lymphoma.
• History of asthma requiring frequent therapy, chronic pulmonary disease, hypertension requiring therapy, or congestive heart failure.
• Any of the symptoms or conditions listed in Exclusion - Co-Existing Conditions.

Prior Medication:

Excluded:

• Any prior therapy with interleukin-2 (IL-2) or PEG IL-2.

Excluded 30 days prior to study entry:

• Treatment with other anti-HIV medication or known immunomodulators or other chemotherapy or radiation therapy.

Active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements.