To investigate the safety of polyethylene glycolated interleukin-2 (PEG IL-2) given
subcutaneously in conjunction with antiviral treatment and to explore the effects of
treatment on surrogate markers of efficacy and incidence of opportunistic infection and
other clinical markers of HIV disease.
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.
Patients must have:
- HIV seropositivity by commercially available ELISA.
- Meet Disease Status criteria.
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.
- 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.
- 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