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

Launched by CHIRON CORPORATION · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.