A randomized, partially blinded phase 2 trial of antiretroviral therapy, HIV-specific immunizations, and interleukin-2 cycles to promote efficient control of viral replication (ACTG A5024)

J. Michael Kilby, R. Pat Bucy, Donna Mildvan, Margaret A Fischl, Jorge Santana-Bagur, Jeff Lennox, Chris Pilcher, Andrew Zolopa, Jody Lawrence, Richard B. Pollard, Raphaelle El Habib, David Sahner, Lawrence Fox, Evgenia Aga, Ronald J. Bosch, Ronald Mitsuyasu

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53 Scopus citations

Abstract

Strategies to limit life-long dependence on antiretroviral therapy (ART) are needed. We randomized 81 human immunodeficiency virus (HIV)-infected subjects to 4 interventional arms involving continued ART plus ALVAC vCP1452 (or placebo) with or without interleukin (IL)-2 infusions. Viral load rebound 12 weeks after ART interruption was then analyzed to assess immune control. Fifty-two subjects reached the study end point. ALVAC recipients had 0.5 log 10 lower virologic rebounds (P = .033). IL-2 plus vaccine boosted CD4 + T cell counts (P < .001) but did not diminish viral rebound. Significant changes were not detected for HIV-specific lymphoproliferative responses in any arm. This exploratory protocol provides useful clinical data for future therapeutic immunization trial design.

Original languageEnglish
Pages (from-to)1672-1676
Number of pages5
JournalJournal of Infectious Diseases
Volume194
Issue number12
DOIs
StatePublished - Dec 15 2006

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ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

Kilby, J. M., Bucy, R. P., Mildvan, D., Fischl, M. A., Santana-Bagur, J., Lennox, J., Pilcher, C., Zolopa, A., Lawrence, J., Pollard, R. B., El Habib, R., Sahner, D., Fox, L., Aga, E., Bosch, R. J., & Mitsuyasu, R. (2006). A randomized, partially blinded phase 2 trial of antiretroviral therapy, HIV-specific immunizations, and interleukin-2 cycles to promote efficient control of viral replication (ACTG A5024). Journal of Infectious Diseases, 194(12), 1672-1676. https://doi.org/10.1086/509508