Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. VaxSyn Protocol Team

AIDS
O PontesilliF Aiuti

Abstract

To alter the natural course of HIV-1 infection by inducing or potentiating immune responses to HIV-1 envelope glycoprotein. Multicentre, double-blind, three-arm, placebo-controlled study. Outpatients attending clinics in two University Hospitals. Ninety-nine asymptomatic HIV-1-infected adults with CD4+ T-cell counts > 400 and < 600 x 10(6)/l and no previous antiretroviral therapy were included. Patients were randomly assigned to three groups treated with: (i) gp160 in alum over a 2-year period in combination with placebo for the full study duration (n = 32); (ii) gp160 in alum over a 2-year period in combination with zidovudine for the full study duration (n = 34); and (iii) alum over a 2-year period in combination with zidovudine for the full study duration (n = 33). Immunotherapy was well tolerated and no significant differences in disease progression were seen in the treatment groups. The majority of patients (85%) receiving gp160 showed persistent lymphoproliferative responses to the immunogen and to a different Env antigen preparation. CD4+ cell count changes in patients receiving zidovudine alone were significantly higher than those seen in patients receiving immunotherapy alone after 1 year of treatment. Zidovudine admin...Continue Reading

References

Jun 1, 1995·Clinical and Experimental Immunology·O PontesilliF Aiuti
Apr 1, 1996·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·A M LevineJ Salk
Jul 10, 1996·JAMA : the Journal of the American Medical Association·C C CarpenterP A Volberding
Mar 1, 1997·Nature Medicine·A M ChinnaiyanG J Nabel
May 1, 1997·Nature Medicine·G Pantaleo

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Citations

Dec 12, 2001·Vaccine·B S Peters
Jul 30, 2002·The Lancet Infectious Diseases·Pierre Vandepapelière
Apr 23, 2002·Clinical and Experimental Immunology·N Imami, F Gotch
May 22, 2001·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·I Sereti, H C Lane
Nov 24, 1999·Immunological Reviews·F GotchN Imami
Jan 27, 2011·Drug Design, Development and Therapy·Lena J Gamble, Qiana L Matthews
Mar 15, 2006·Journal of Immunotherapy·Glenn A Van den BoschViggo F I Van Tendeloo
Dec 12, 2001·HIV Medicine·F M GotchG Hardy
Dec 1, 2001·Expert Opinion on Biological Therapy·N ImamiF Gotch
Jan 31, 2002·HIV Clinical Trials·Vichai Jirathitikal, Aldar S Bourinbaiar
May 22, 2003·Dermatologic Clinics·Mathijs H BrentjensStephen K Tyring
Sep 18, 1999·Lancet·O Pontesilli, F Aiuti
May 29, 2012·Human Vaccines & Immunotherapeutics·Felipe GarcíaTeresa Gallart
Apr 26, 2000·Clinical Immunology : the Official Journal of the Clinical Immunology Society·R B MossD J Carlo
Feb 13, 2001·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·H Thaker, E L Ong
Jan 6, 2001·Antiviral Chemistry & Chemotherapy·B S Peters
Dec 13, 2005·Clinical Science·Rebekah L Puls, Sean Emery

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