title: 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).
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.
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL 35294-2050, USA. mkilby@uab.edu
authors.forename: J Michael
authors.initials: JM
authors.lastname: Kilby
authors.forename: R Pat
authors.initials: RP
authors.lastname: Bucy
authors.forename: Donna
authors.initials: D
authors.lastname: Mildvan
authors.forename: Margaret
authors.initials: M
authors.lastname: Fischl
authors.forename: Jorge
authors.initials: J
authors.lastname: Santana-Bagur
authors.forename: Jeff
authors.initials: J
authors.lastname: Lennox
authors.forename: Chris
authors.initials: C
authors.lastname: Pilcher
authors.forename: Andrew
authors.initials: A
authors.lastname: Zolopa
authors.forename: Jody
authors.initials: J
authors.lastname: Lawrence
authors.forename: Richard B
authors.initials: RB
authors.lastname: Pollard
authors.forename: Raphaelle El
authors.initials: RE
authors.lastname: Habib
authors.forename: David
authors.initials: D
authors.lastname: Sahner
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fox
authors.forename: Evgenia
authors.initials: E
authors.lastname: Aga
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Bosch
authors.forename: Ronald
authors.initials: R
authors.lastname: Mitsuyasu
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage*; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D015658:HIV Infections / Q000276:immunology* / Q000628:therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D016312:Treatment Refusal; D014611:Vaccination; D019562:Viral Load
chemical_list: D016915:AIDS Vaccines; C468116:ALVAC-HIV vCP1452; D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D007376:Interleukin-2; D012367:RNA, Viral; D011994:Recombinant Proteins; C082598:aldesleukin