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)

Kilby, J. Michael; Bucy, R. Pat; Mildvan, Donna; Fischl, Margaret; Santana-Bagur, Jorge; Lennox, Jeff; Pilcher, Chris; Zolopa, Andrew; Lawrence, Jody; Pollard, Richard B.; El Habib, Raphaelle; Sahner, David; Fox, Lawrence; Aga, Evgenia; Bosch, Ronald J.; Mitsuyasu, Ronald
December 2006
Journal of Infectious Diseases;12/15/2006, Vol. 194 Issue 12, p1672
Academic Journal
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.


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