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).

TitleA 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).
Publication TypeJournal Article
Year of Publication2006
AuthorsJ Kilby M, R Bucy P, Mildvan D, Fischl M, Santana-Bagur J, Lennox J, Pilcher C, Zolopa A, Lawrence J, Pollard RB, Habib REl, Sahner D, Fox L, Aga E, Bosch RJ, Mitsuyasu R
Corporate AuthorsAdult AIDS Clinical Trials Group A5024 Protocol Team
JournalJ Infect Dis
Volume194
Issue12
Pagination1672-6
Date Published2006 Dec 15
ISSN0022-1899
KeywordsAdult, AIDS Vaccines, Anti-HIV Agents, Anti-Retroviral Agents, CD4 Lymphocyte Count, Drug Therapy, Combination, Endpoint Determination, HIV Infections, HIV-1, Humans, Injections, Subcutaneous, Interleukin-2, Recombinant Proteins, RNA, Viral, Treatment Refusal, Vaccination, Viral Load
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.

DOI10.1086/509508
Alternate JournalJ. Infect. Dis.
PubMed ID17109338
Grant ListAI 25859 / AI / NIAID NIH HHS / United States
AI 25868 / AI / NIAID NIH HHS / United States
AI 25915 / AI / NIAID NIH HHS / United States
AI 27658 / AI / NIAID NIH HHS / United States
AI 27660 / AI / NIAID NIH HHS / United States
AI 27661 / AI / NIAID NIH HHS / United States
AI 27663 / AI / NIAID NIH HHS / United States
AI 27666 / AI / NIAID NIH HHS / United States
AI 27673 / AI / NIAID NIH HHS / United States
AI 27675 / AI / NIAID NIH HHS / United States
AI 32770 / AI / NIAID NIH HHS / United States
AI 32775 / AI / NIAID NIH HHS / United States
AI 32782 / AI / NIAID NIH HHS / United States
AI 32783 / AI / NIAID NIH HHS / United States
AI 34832 / AI / NIAID NIH HHS / United States
AI 34853 / AI / NIAID NIH HHS / United States
AI 38855 / AI / NIAID NIH HHS / United States
AI 38858 / AI / NIAID NIH HHS / United States
AI 46339 / AI / NIAID NIH HHS / United States
AI 46370 / AI / NIAID NIH HHS / United States
M01 RR-00032 / RR / NCRR NIH HHS / United States