A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115.

A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Research Abstract Details 

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A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Abstract Text:

Sharon A Riddler,Hongyu Jiang,Allan Tenorio,Hairong Huang,Daniel R Kuritzkes,Edward P Acosta,Alan Landay,Barbara Bastow,David W Haas,Karen T Tashima,Mamta K Jain,Steven G Deeks,John A Bartlett,

BACKGROUND: Clinical stability has been observed with continued antiretroviral therapy (ART) in the setting of partial virological suppression. The optimal time to switch treatment in patients with low but detectable HIV-1 RNA is not known. METHODS: Subjects on stable ART with HIV-1 RNA 200-10,000 copies/ml were randomized to an immediate treatment switch, or to a delayed switch when HIV-1 RNA increased to > or = 10,000 copies/ml or CD4+ T-cell count decreased by 20%. The primary outcome measures were immune activation (proportion of CD8+ T-cells expressing CD38 at week 48) and evolution of genotypic drug resistance. RESULTS: The study failed to fully accrue the originally planned 108 subjects. Only 47 subjects were randomized to immediate- or delayed-switch arms. Of the subjects in the delayed-switch arm, 10/23 (43%) met the criteria for ART switch during the study (median follow-up 82 weeks). After 48 weeks of observation, the level of immune activation was comparable in the two arms. New resistance mutations were observed in 3/17 and 8/19 subjects in the immediate- and delayed-switch groups, respectively. The loss of future treatment options, however, was comparable in the delayed- and immediate-switch groups. CONCLUSIONS: Individuals with partial viral suppression tend to remain immunologically stable, however, the accumulation of drug resistance mutations is an ongoing risk. Delayed switch in ART may be a reasonable short-term strategy for individuals with very limited treatment options.

A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Publishing Authors By Initials

SA Riddler,H Jiang,A Tenorio,H Huang,DR Kuritzkes,EP Acosta,A Landay,B Bastow,DW Haas,KT Tashima,MK Jain,SG Deeks,JA Bartlett,

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A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Journal Published:

PUBLICATION TYPE: Research Support, N.I.H., Extr

Journal: Antiviral therapy

VOLUME: 12

Page Numbers: 531-41

Journal Abbreviation: Antivir. Ther. (Lond.)

ISSN: 1359-6535

DAY: 2

MONTH: 08

YEAR: 2007

A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Information

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LANGUAGE: eng

NlmUniqueID: 9815705

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Grant and Affiliation Information for A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115.

AFFILIATION: Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. riddler@dom.pitt.edu

Country: England

AGENCY: United States NIAID

GRANT: U01 AI27659

ACRONYM: AI

MEDLINETA: Antivir Ther

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