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

Status Completed

Clinical Trial Summary

To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). 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.

Clinical Trial Description

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 back by either the intradermal (ID) or subcutaneous (SC) route, to establish an optimal dose (which when given ID results in local induration = or > 25 mm without significant toxicity). The ID and SC routes are compared for systemic effect and toxicity. In the second phase of the study, the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage, frequency, and route determined in the initial phase (probably 2-3 times per week) while local and systemic effects are monitored. These include measures of viral titer, peripheral blood mononuclear cell phenotype, CBC and CD4 counts, and in vitro cytotoxicity assays. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00002017
Study type	Interventional
Source	NIH AIDS Clinical Trials Information Service
Contact
Status	Completed
Phase	N/A

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