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

Research output: Contribution to journalArticle

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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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Interleukin-2
Immunization
HIV
Therapeutics
CD4 Lymphocyte Count
Viral Load
Vaccines
Placebos
T-Lymphocytes

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

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 A; 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.

In: Journal of Infectious Diseases, Vol. 194, No. 12, 15.12.2006, p. 1672-1676.

Research output: Contribution to journalArticle

Kilby, JM, Bucy, RP, Mildvan, D, Fischl, MA, Santana-Bagur, J, Lennox, J, Pilcher, C, Zolopa, A, Lawrence, J, Pollard, RB, El Habib, R, Sahner, D, Fox, L, Aga, E, Bosch, RJ & 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, vol. 194, no. 12, pp. 1672-1676. https://doi.org/10.1086/509508
Kilby, J. Michael ; Bucy, R. Pat ; Mildvan, Donna ; Fischl, Margaret A ; 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. / 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). In: Journal of Infectious Diseases. 2006 ; Vol. 194, No. 12. pp. 1672-1676.
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