Polyethylene Glycol-Modified Interleukin-2 and Thymosin 1 in Human Immunodeficiency Virus Type 1 Infection

Abstract
The safety and antiviral effects of polyethylene glycolated interleukin-2 (PEG-IL-2) and thymosin α1 in addition to zidovudine were studied in 12 human immunodeficiency virus (HIV)-infected subjects with 50–250 CD4 T cells/mm3, PEG-IL-2 was administered by intravenous infusions every 2 weeks at 106 IU/m2 for 20 weeks. Thymosin α1 was administered subcutaneously at 400 µg/m2 after four doses of PEG-IL-2, escalating to 1600 µg/m2 weekly for an additional 2 months. Significant elevations of CD4 T cell numbers of 30%–40% were seen after PEG-IL-2 infusions, but no additional increase in CD4 cell count was observed with thymosin at. Virologic monitoring by polymerase chain reaction quantitation of proviral DNA and plasma RNA and p24 antigen assays showed no evidence of increased HIV activation during PEG-IL-2 or thymosin at therapy. Patients tolerated both PEG-IL-2 and thymosin α1 without significant toxicities.

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