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Updated: Oct 1, 2026

In Vitro Assay to Evaluate the Impact of Immunoregulatory Pathways on HIV-specific CD4 T Cell Effector Function
Published on: October 15, 2013
Pharmacokinetics and pharmacodynamics of subcutaneous interleukin-2 in HIV-infected patients
S C Piscitelli1, M J Wells, J A Metcalf
1Department of Pharmacy, Warren G. Magnuson Clinical Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA. spisc@nih.gov
Study Objectives:
To assess the pharmacokinetics and pharmacodynamics of subcutaneously administered interleukin-2 (IL-2) in patients infected with the human immunodeficiency virus (HIV).
Design:
Open, dose-escalating phase I clinical trial.
Setting:
Government research hospital.
Patients:
Eighteen patients infected with HIV.
Interventions:
Recombinant IL-2 at dosages of 12, 15, or 18 MIU/day was administered subcutaneously once or twice/day for 5 consecutive days every 2 months. A total of 28 cycles of therapy were included in the analysis.
Measurements And Main Results:
Concentrations of IL-2 in serum were determined by a commercial enzyme-linked immunosorbent assay. Interleukin-2 was well absorbed, with peak concentrations from 21.9-112.9 IU/ml. Absorption was slow, with mean (+/- SD) time to maximum of 4.4 +/- 1.8 hours and a lag time of 26.9 +/- 13.7 minutes. Elimination half-life was 3.3 +/- 0.9 hours. The concentrations had wide variability both within and among patients. Levels of tumor necrosis factor-alpha were increased. Maximum body temperature and systemic side effects were associated with peak serum levels.
Conclusion:
Interleukin-2 is well absorbed after subcutaneous injection in HIV-infected patients, and that route of administration is an alternative to intravenous infusions.
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