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

Ronald J. Bosch, Richard B Pollard, Alan Landay, Evgenia Aga, Lawrence Fox, Ronald Mitsuyasu

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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/mm3 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 log10 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.

Original languageEnglish (US)
Pages (from-to)481-483
Number of pages3
JournalJournal of Interferon and Cytokine Research
Volume31
Issue number6
DOIs
StatePublished - Jun 1 2011

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Interleukin-2
HIV
Immunity
HIV-1
HIV Antigens
RNA
CD4 Lymphocyte Count
Nonparametric Statistics
Acquired Immunodeficiency Syndrome
Clinical Trials
T-Lymphocytes

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Cell Biology

Cite this

A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment. / Bosch, Ronald J.; Pollard, Richard B; Landay, Alan; Aga, Evgenia; Fox, Lawrence; Mitsuyasu, Ronald.

In: Journal of Interferon and Cytokine Research, Vol. 31, No. 6, 01.06.2011, p. 481-483.

Research output: Contribution to journalArticle

Bosch, Ronald J. ; Pollard, Richard B ; Landay, Alan ; Aga, Evgenia ; Fox, Lawrence ; Mitsuyasu, Ronald. / A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment. In: Journal of Interferon and Cytokine Research. 2011 ; Vol. 31, No. 6. pp. 481-483.
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