Drug Safety

, Volume 22, Issue 1, pp 19–31 | Cite as

A Risk-Benefit Assessment of Interleukin-2 as an Adjunct to Antiviral Therapy in HIV Infection

Review Article


Immunomodulation has become a major focus of HIV research in an effort to augment, boost or restore the patient’s damaged immune system. Recombinant interleukin-2 is currently being studied in phase II/III trials in HIV-infected patients. Several clinical studies have demonstrated that intermittent regimens are associated with marked rises in CD4+ cell counts without an increase in viral load. Most of these studies employ 5 consecutive days of interleukin-2 therapy by continuous intravenous infusion or subcutaneous injection, repeated every 8 weeks. An alternative strategy is the daily administration of low doses of interleukin-2, but clinical experience with this regimen is limited.

Interleukin-2 administration can adversely affect virtually every organ system, requiring aggressive supportive care. A variety of administration strategies and interventions are being evaluated to minimise toxicity.

Currently, no clinical end-point data are available for interleukin-2 in HIV-infected patients. Until phase III studies are completed, interleukin-2 can be used in the research setting as an immunomodulator and adjunct to antiretroviral therapy. Its potential to activate latently infected cells and promote HIV eradication from reservoir sites is also an important area for further study. If clinical benefit can be demonstrated, interleukin-2 could be useful as an adjunct to antiretroviral therapy if adverse effects can beminimised and therapy can be given infrequently on an outpatient basis.


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Copyright information

© Adis International Limited 2000

Authors and Affiliations

  • Stephen C. Piscitelli
    • 1
  • Niranjan Bhat
    • 2
  • Alice Pau
    • 1
  1. 1.Clinical Center Pharmacy DepartmentNational Institute of Allergy and Infectious Diseases, National Institutes of HealthBethesdaUSA
  2. 2.Laboratory of ImmunoregulationNational Institute of Allergy and Infectious Diseases, National Institutes of HealthBethesdaUSA

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