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1 September 2006

Volume 194, Number 5
The Journal of Infectious Diseases 2006;194:623–632
© 2006 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2006/19405-0014$15.00
DOI: 10.1086/506364
MAJOR ARTICLE

Evidence That Intermittent Structured Treatment Interruption, but Not Immunization with ALVAC‐HIV vCP1452, Promotes Host Control of HIV Replication: The Results of AIDS Clinical Trials Group 5068

Jeffrey M. Jacobson,1

R. Pat Bucy,4

John Spritzler,6

Michael S. Saag,4

Joseph J. Eron, Jr.,7

Robert W. Coombs,8

Rui Wang,6

Lawrence Fox,9

Victoria A. Johnson,4,5

Susan Cu‐Uvin,11

Susan E. Cohn,2

Donna Mildvan,1

Dorothy O’Neill,10

Jennifer Janik,3

Lynette Purdue,9

Deborah K. O’Connor,12

Christine Di Vita,13

Ian Frank,14 and the

National Institute of Allergy and Infectious Diseases–AIDS Clinical Trials Group 5068 Protocol Teama

1Beth Israel Medical Center and Albert Einstein College of Medicine, New York, 2University of Rochester, Rochester, and 3Frontier Science, Amherst, New York; 4University of Alabama and 5Birmingham Veterans Administration Medical Center, Birmingham; 6Harvard School of Public Health, Boston, Massachusetts; 7University of North Carolina, Chapel Hill; 8University of Washington, Seattle; 9National Institute of Allergy and Infectious Diseases, Bethesda, and 10Social and Scientific Systems, Silver Spring, Maryland; 11Brown University, Providence, Rhode Island; 12Indiana University, Indianapolis; 13Sanofi Pasteur, Lyon, France; 14University of Pennsylvania, Philadelphia

Background.The ability to control human immunodeficiency virus (HIV) replication in vivo in the absence of antiretroviral therapy (ART) is a measure of the efficiency of antiviral immunity. In a study of patients with chronic, ART‐suppressed HIV infection, AIDS Clinical Trials Group 5068 investigated the effects of immunization with an exogenous HIV vaccine and pulse exposure to the subject’s unique viral epitopes, by means of structured treatment interruptions (STIs), on the dynamics of viral rebound during a subsequent analytical treatment interruption (ATI).

Methods.Ninety‐seven subjects receiving stable ART with an HIV‐1 RNA load <50 copies/mL and CD4+ T lymphocyte count >400 cells/mm3 were randomized to undergo continued ART, STIs, ALVAC‐HIV vCP1452 immunization, or STIs and ALVAC‐HIV vCP1452 immunization.

Results.Subjects in the 2 STI arms had a significantly longer median doubling time in the period of the initial rise of viral load, a significantly lower median peak viral load, a significantly lower median end‐of‐ATI viral load set point, and a greater proportion of subjects with an end‐of‐ATI viral load set point <1000 copies/mL, compared with the subjects in the 2 arms without STIs. With an immunization schedule of 3 sets of 3 weekly injections, ALVAC‐HIV vCP1452 did not affect viral load measures.

Conclusions.In this randomized, controlled study of intermittent STI as a therapeutic autoimmunization strategy, evidence of enhanced immunologic control of HIV replication was demonstrated.

Received 31 January 2006; accepted 12 April 2006; electronically published 1 August 2006.

Reprints or correspondence: Dr. Jeffrey M. Jacobson, Beth Israel Medical Center, Div. of Infectious Diseases, First Ave. at 16th St., 19BH14, New York, NY 10003 ().

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  • Presented in part: 3rd IAS Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, Brazil, July 2005 (abstract Tufe 13.2B01); AIDS Vaccine 2005 Conference, Montreal, Canada, September 2005.

    Potential conflicts of interest: C.D.V. is an employee of Sanofi‐Pasteur. J.M.J. and R.P.B. attended a Sanofi‐Pasteur advisory board meeting. All other authors report no potential conflicts of interest.

    Financial support provided to this study is listed in Acknowledgments.

    Clinical trial registration number: NCT00011011 (http://www.clinicaltrials.gov).

  • Other participating investigators are listed at the end of the text.

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