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 Kilby, J. M., Bucy, R. P., Mildvan, D., Fischl, M., 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; 194 (12): 1672-1676


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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View details for PubMedID 17109338