Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2

Launched by ROCKEFELLER UNIVERSITY · Aug 30, 2001

Keywords

ClinConnect Summary

Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.

In the first, dose-escalation phase of the study, PEG-IL-2 is injected into the skin of the ba...

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Zidovudine (AZT).
• • Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
• • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
• • Oral antibiotics for PCP prophylaxis if hematologically stable for = or \> 30 days prior to study entry.
• • Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
• Patients must have:
• • HIV-1 seropositivity.
• • Asymptomatic.
• • No opportunistic infection for 8 weeks prior to study entry.
• • Been on azidothymidine (AZT) (= or \> 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts.
• Prior Medication:
• Allowed:
• • Zidovudine (AZT).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
• • Fever = or \> 101 F. within 10 days prior to study entry.
• • Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
• • Significant cardiac disease (New York Heart Association Stage III or IV).
• • Significant pulmonary disease (Forced Expiratory Volume \< 75 percent.
• • Weight loss = or \> 10 percent within last 3 months.
• Concurrent Medication:
• Excluded:
• • Systemic therapy for opportunistic infection (OI).
• Patients with the following are excluded:
• • Presence of antibody to interleukin-2 (IL-2).
• • Diseases or symptoms listed in Exclusion Co-Existing Conditions.
• Prior Medication:
• Excluded within 12 weeks prior to study entry:
• • Other immunomodulators.
• • Corticosteroids.
• • Other experimental therapy.
• • Anti-neoplastic chemotherapy.
• • Active drug or alcohol abuse.