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).
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.
Kilby
J Michael
JM
University of Alabama at Birmingham, Birmingham, AL 35294-2050, USA. mkilby@uab.edu
Bucy
R Pat
RP
Mildvan
Donna
D
Fischl
Margaret
M
Santana-Bagur
Jorge
J
Lennox
Jeff
J
Pilcher
Chris
C
Zolopa
Andrew
A
Lawrence
Jody
J
Pollard
Richard B
RB
Habib
Raphaelle El
RE
Sahner
David
D
Fox
Lawrence
L
Aga
Evgenia
E
Bosch
Ronald J
RJ
Mitsuyasu
Ronald
R
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
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