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 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

Research output: Contribution to journalArticlepeer-review

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

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

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