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)

• Published in: The Journal of infectious diseases 2006-12, Vol.194 (12), p.1672-1676
• Main Authors: Kilby, J. Michael , Bucy, R. Pat , Mildvan, Donna , Fischl, Margaret , Santana‐Bagur, Jorge , Lennox, Jeff , Pilcher, Chris , Zolopa, Andrew , Lawrence, Jody , Pollard, Richard B. , Habib, Raphaelle El , Sahner, David , Fox, Lawrence , Aga, Evgenia , Bosch, Ronald J.
• Format: Article
• Language: English
• Subjects: Adult; AIDS; AIDS Vaccines - administration & dosage; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - therapeutic use; Anti-Retroviral Agents - therapeutic use; Antiretrovirals; Arts; CD4 Lymphocyte Count; Drug Therapy, Combination; Endpoint Determination; HIV; HIV Infections - immunology; HIV Infections - therapy; HIV Infections - virology; HIV-1 - genetics; HIV-1 - immunology; HIV-1 - isolation & purification; HIV/AIDS; Human immunodeficiency virus; Humans; Immunization; Injections, Subcutaneous; Interleukin-2 - administration & dosage; Interleukin-2 - analogs & derivatives; Interleukin-2 - therapeutic use; Medical treatment; Placebos; Recombinant Proteins - administration & dosage; Recombinant Proteins - therapeutic use; RNA, Viral - blood; T lymphocytes; Treatment Refusal; Vaccination; Viral Load
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/509508

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 log10 lower virologic rebounds (P=.033). IL‐2 plus vaccine boosted CD4+ T cell counts (P