A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment

J Interferon Cytokine Res. 2011 Jun;31(6):481-3. doi: 10.1089/jir.2010.0119. Epub 2011 Feb 3.


In HIV-infected individuals on antiretroviral treatment with viral suppression, structured treatment interruptions are designed to allow exposure to endogenous HIV antigens and to thereby boost HIV-specific immunity. AIDS Clinical Trials Group A5132 was an exploratory 2-arm randomized trial that evaluated two 4-week treatment interruptions in combination with 2 strategies for administering interleukin-2 (IL-2): 2.0 million international units of IL-2 subcutaneously daily during the final 2 weeks of treatment interruption and the first week of treatment reinitiation (arm A), or 4.5 million international units of IL-2 subcutaneously twice a day during the first 5 days of treatment reinitiation (arm B). Twenty-one subjects with HIV-1 RNA <50 copies/mL and CD4+ T cell counts ≥300 (median 615) cells/mm(3) were randomized. The primary endpoint was the viral setpoint measured 11-12 weeks after a third treatment interruption (observed for 7 Arm A and 9 Arm B). The median HIV-1 RNA setpoints were 4.3 and 4.5 log(10) copies/mL for Arm A and Arm B, respectively; there was no evidence of a difference between arms (P = 0.50, rank-sum test, worst rank for unobserved viral setpoint). The current study, the first to evaluate IL-2 during repeated short-term treatment interruptions, revealed no evidence for augmentation of HIV immunity. Viral setpoints were similar to historical controls, emphasizing the need for new strategies to enhance HIV-specific immunity.

Trial registration: ClinicalTrials.gov NCT00038259.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Antiretroviral Therapy, Highly Active
  • Clinical Protocols
  • Female
  • Follow-Up Studies
  • HIV / pathogenicity
  • HIV / physiology*
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • Humans
  • Immunotherapy*
  • Interleukin-2 / administration & dosage*
  • Male
  • Middle Aged
  • RNA, Viral / analysis*
  • Virus Replication
  • Withholding Treatment


  • Adjuvants, Immunologic
  • Interleukin-2
  • RNA, Viral

Associated data

  • ClinicalTrials.gov/NCT00038259