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.
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Multicenter Study
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Randomized Controlled Trial
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Research Support, N.I.H., Extramural
MeSH terms
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AIDS Vaccines / administration & dosage*
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Adult
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Anti-HIV Agents / administration & dosage
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Anti-HIV Agents / therapeutic use*
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Anti-Retroviral Agents / therapeutic use*
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CD4 Lymphocyte Count
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Drug Therapy, Combination
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Endpoint Determination
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HIV Infections / immunology*
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HIV Infections / therapy*
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HIV Infections / virology
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HIV-1 / genetics
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HIV-1 / immunology*
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HIV-1 / isolation & purification
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Humans
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Injections, Subcutaneous
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Interleukin-2 / administration & dosage
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Interleukin-2 / analogs & derivatives*
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Interleukin-2 / therapeutic use*
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RNA, Viral / blood
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Recombinant Proteins / administration & dosage
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Recombinant Proteins / therapeutic use
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Treatment Refusal
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Vaccination*
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Viral Load
Substances
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AIDS Vaccines
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ALVAC-HIV vCP1452
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Anti-HIV Agents
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Anti-Retroviral Agents
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Interleukin-2
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RNA, Viral
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Recombinant Proteins
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aldesleukin