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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiron Corporation
• Treatments: Didanosine; Interleukin-2; Zidovudine

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.