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
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Comparative Study
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Research Support, Non-U.S. Gov't
MeSH terms
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AIDS Vaccines / administration & dosage
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AIDS Vaccines / therapeutic use*
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Adult
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Anti-HIV Agents / adverse effects
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Anti-HIV Agents / therapeutic use*
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Chemokines / metabolism
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Combined Modality Therapy
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Endpoint Determination
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Female
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HIV Envelope Protein gp120 / immunology
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HIV Infections / drug therapy
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HIV Infections / immunology
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HIV Infections / therapy*
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HIV-1 / immunology*
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Humans
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Immunity, Cellular / drug effects
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Immunity, Cellular / immunology
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Interferon-gamma / biosynthesis
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Interferon-gamma / genetics
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Lymphoproliferative Disorders / immunology
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Lymphoproliferative Disorders / pathology
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Male
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T-Lymphocytes, Helper-Inducer / immunology
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Th1 Cells / immunology
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Vaccines, Inactivated / therapeutic use
Substances
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AIDS Vaccines
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Anti-HIV Agents
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Chemokines
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HIV Envelope Protein gp120
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Vaccines, Inactivated
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Interferon-gamma