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Updated: Jul 25, 2026
In Vitro Assay to Evaluate the Impact of Immunoregulatory Pathways on HIV-specific CD4 T Cell Effector Function
Published on: October 15, 2013
A phase I study of subcutaneous recombinant interleukin-2 in patients with advanced HIV disease while on zidovudine
D K McMahon1, J A Armstrong, X L Huang
1Department of Infectious Diseases and Microbiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania 15261.
Objective:
A Phase I study of subcutaneous recombinant interleukin-2 (rIL-2).
Design:
Sixteen patients with advanced HIV infection receiving 600-1200 mg zidovudine per day were divided into three groups, which received sequentially 0.2 x 10(6), 0.7 x 10(6) or 2 x 10(6) units/m2 per day of rIL-2 subcutaneously 5 consecutive days.
Setting:
Five-day admission to an academic tertiary care hospital.
Patients, Participants:
Sixteen unblinded, non-randomized volunteers.
Interventions:
Subcutaneous rIL-2.
Main Outcome Measures:
Tolerance, toxicity, hematologic, immunologic and antiviral responses.
Results:
rIL-2 was well-tolerated at the highest dosage, except in two patients who developed significant lymphopenia by the second day of rIL-2 administration, with rebound within 48 h after rIL-2 therapy. The number of eosinophils, CD4+ and CD8+ cells, and percentage of CD16+ (natural killer) cells, remained elevated above baseline for up to 10 weeks. Circulating rIL-2 receptor levels increased transiently during and immediately following rIL-2 administration. A twofold increase in natural killer cell activity against uninfected and HIV-infected targets was observed, but did not persist beyond 10 weeks following rIL-2 administration. There was a transient decrease in blastogenesis to phytohemagglutinin of patients receiving the highest dose of r-IL-2, but no significant change in viral burden.
Conclusions:
Subcutaneous rIL-2 in advanced HIV-infected patients on zidovudine was tolerated with side-effects similar to intravenous IL-2.
