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1 November 2006

Volume 194, Number 9
The Journal of Infectious Diseases 2006;194:1309–1318
© 2006 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2006/19409-0017$15.00
DOI: 10.1086/508289
MAJOR ARTICLE

A Randomized Trial of Treatment Interruption before Optimized Antiretroviral Therapy for Persons with Drug‐Resistant HIV: 48‐Week Virologic Results of ACTG A5086

Constance A. Benson,1

Florin Vaida,1

Diane V. Havlir,2

Gerald F. Downey,3

Michael M. Lederman,4

Roy M. Gulick,5

Marshall J. Glesby,5

Michael Wantman,3

Christian J. Bixby,6

Alex R. Rinehart,7

Sally Snyder,8

Rui Wang,3

Sheran Patel,6 and

John W. Mellors,6 for the

ACTG A5086 Study Teama

1University of California, San Diego School of Medicine, San Diego, and 2San Francisco General Hospital and University of California, San Francisco School of Medicine, San Francisco; 3Harvard School of Public Health, Boston, Massachusetts; 4Case Western Reserve University School of Medicine, Cleveland, Ohio; 5Weill Medical College of Cornell University, New York, New York; 6University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; 7Virco Lab, Inc., Tibotec‐Virco, Durham, North Carolina; 8Social and Scientific Systems, Inc., Silver Spring, Maryland

Background.The role of structured treatment interruption (STI) before optimized antiretroviral therapy (ART) in patients with drug‐resistant human immunodeficiency virus type 1 (HIV‐1) is uncertain.

Methods.AIDS Clinical Trial Group protocol A5086 was a prospective trial of 41 patients with multiple drug class–resistant HIV who were randomized to undergo a 16‐week STI followed by optimized ART (STI) or immediate optimized ART (no STI). The primary end point was the proportion of subjects with HIV‐1 RNA loads <400 copies/mL 48 weeks after randomization.

Results.Of 39 evaluable patients, 4 (19%) in the STI arm and 6 (33%) in the no STI arm had HIV‐1 RNA loads <400 copies/mL at 48 weeks ( ). Median changes from baseline in CD4+ cell counts and HIV‐1 RNA loads were similar for both arms. Standard genotypes at the end of STI showed nearly complete reversion to wild‐type virus in a minority of patients ( ; 28%). Virus with 3–drug class resistance reemerged even when ART included only 1 or 2 drug classes. Single‐genome sequencing showed that each genome encoded resistance mutations for 3 drug classes.

Conclusions.A 16‐week STI before optimized ART did not improve virologic response. Genetic analyses strongly suggest that virologic failure resulted from the reemergence of virus present before STI that encoded 3–drug class resistance on the same genome.

Received 26 January 2006; accepted 4 July 2006; electronically published 22 September 2006.

Reprints or correspondence: Dr. Constance A. Benson, Antiviral Research Center, University of California, San Diego, 150 W. Washington St., Ste. 100, San Diego, CA 92103 ().

Cited by

Giovanina M Ellis, Libby C Page, Blaire E Burman, Susan Buskin, Lisa M Frenkel. (2009) Increased Detection of HIV-1 Drug Resistance at Time of Diagnosis by Testing Viral DNA With a Sensitive Assay. JAIDS Journal of Acquired Immune Deficiency Syndromes 51:3, 283-289
Online publication date: 1-Aug-2009.
CrossRef
Joseph J. Eron. (2008) Managing Antiretroviral Therapy: Changing Regimens, Resistance Testing, and the Risks from Structured Treatment Interruptions. The Journal of Infectious Diseases 197:s3, S261-S271
Online publication date: 15-May-2008.
Abstract-Full Text-PDF Version (468 kB)
Jeffrey M Jacobson. (2007) Role of structured treatment interruption in HIV infection. Future HIV Therapy 1:1, 73-80
Online publication date: 1-Jun-2007.
CrossRef

  • Presented in part: 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, 8–11 February 2004 (abstract 58).

    Financial support: National Institutes of Health (grants AI 38858, AI 27670, AI 38855, AI 51951, AI 27663, AI 46383, AI 46386, AI 51966, RR 0047, AI 25879, AI 32770, RR 00051, P30‐AI 27767, AI 32775, RR 00032, AI 27665, RR 00096, AI 46370, AI 46339, AI 25859, AI 27660, AI 34853, AI 34832, and AI 25897).

    Potential conflicts of interest: A.R.R. is an employee of Tibotec Therapeutics, the parent company of Virco, which manufactured the drug‐resistance assays used in the study. All other authors: no conflicts reported.

    Clinical trials registry: NCT00011128 (http://www.ClinicalTrials.gov).

  • Study group members are listed after the text.

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