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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)

2006; Oxford University Press; Volume: 194; Issue: 12 Linguagem: Inglês

10.1086/509508

1537-6613

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, Raphaëlle El Habib, David Sahner, Lawrence Fox, Evgenia Aga, Ronald J. Bosch, Ronald T. Mitsuyasu,

HIV/AIDS drug development and treatment

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.