Therapeutic immunization with an inactivated HIV-1 Immunogen plus antiretrovirals versus antiretroviral therapy alone in asymptomatic HIV-infected subjects

Vaccine. 2004 Aug 13;22(23-24):2966-73. doi: 10.1016/j.vaccine.2004.03.040.

Abstract

To determine whether the addition of an inactivated-gp120-depleted HIV-1 Immunogen to antiretrovirals (ARTs) conferred a beneficial effect on delaying time to virologic failure relative to that obtained by ARTs alone, a phase II clinical trial was performed in 243 asymptomatic, ART naïve, HIV-1 seropositive adults. The Cox model showed that HIV-1 Immunogen treatment was associated with a 34% decrease in the risk of virologic failure (P = 0.056). When the analysis incorporated baseline HIV-RNA stratification the risk of virologic failure in the HIV-1 Immunogen Arm was significantly reduced a 37% compared to the IFA placebo Arm (P = 0.034). The data suggest that therapeutic immunization plus ARTs could influence virologic control.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / administration & dosage
  • AIDS Vaccines / therapeutic use*
  • Adult
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Chemokines / metabolism
  • Combined Modality Therapy
  • Endpoint Determination
  • Female
  • HIV Envelope Protein gp120 / immunology
  • HIV Infections / drug therapy
  • HIV Infections / immunology
  • HIV Infections / therapy*
  • HIV-1 / immunology*
  • Humans
  • Immunity, Cellular / drug effects
  • Immunity, Cellular / immunology
  • Interferon-gamma / biosynthesis
  • Interferon-gamma / genetics
  • Lymphoproliferative Disorders / immunology
  • Lymphoproliferative Disorders / pathology
  • Male
  • T-Lymphocytes, Helper-Inducer / immunology
  • Th1 Cells / immunology
  • Vaccines, Inactivated / therapeutic use

Substances

  • AIDS Vaccines
  • Anti-HIV Agents
  • Chemokines
  • HIV Envelope Protein gp120
  • Vaccines, Inactivated
  • Interferon-gamma