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Title: CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial
Authors: Jintanat Ananworanich
Angèle Gayet-Ageron
Michelle Le Braz
Wisit Prasithsirikul
Ploenchan Chetchotisakd
Sasisopin Kiertiburanakul
Warangkana Munsakul
Phitsanu Raksakulkarn
Somboon Tansuphasawasdikul
Sunee Sirivichayakul
Matthias Cavassini
Urs Karrer
Daniel Genné
Reto Nüesch
Pietro Vernazza
Enos Bernasconi
Dominic Leduc
Claudette Satchell
Sabine Yerly
Luc Perrin
Andrew Hill
Thomas Perneger
Praphan Phanuphak
Hansjakob Furrer
David Cooper
Kiat Ruxrungtham
Bernard Hirschel
The HIV Netherlands Australia Thailand Research Collaboration
Hopitaux universitaires de Geneve
Bamrasnaradura Infectious Disease Institute
Khon Kaen University
Mahidol University
Vajira Hospital
Sanpatong Hospital
Buddhachinnaraj Hospital
UniversitatsSpital Bern
University of Liverpool
Kirby Institute
Chulalongkorn University
Centre Hospitalier Universitaire Vaudois
UniversitatsSpital Zurich
La Chaux-de-Fonds Hospital
Universitatsspital Basel
Kantonsspital St Gallen
Ospedale Civico, Lugano
Hôpital d'Annemasse
Keywords: Medicine
Issue Date: 5-Aug-2006
Citation: Lancet. Vol.368, No.9534 (2006), 459-465
Abstract: Background: Stopping antiretroviral therapy in patients with HIV-1 infection can reduce costs and side-effects, but carries the risk of increased immune suppression and emergence of resistance. Methods: 430 patients with CD4-positive T-lymphocyte (CD4) counts greater than 350 cells per μL, and viral load less than 50 copies per mL were randomised to continued therapy (n=146) or scheduled treatment interruptions (n=284). Median time on randomised treatment was 21·9 months (range 16·4-25·3). Primary endpoints were proportion of patients with viral load less than 50 copies per mL at the end of the trial, and amount of drugs used. Analysis was intention-to-treat. This study is registered at with the identifier NCT00113126. Findings: Drug savings in the scheduled treatment interruption group, compared with continuous treatment, amounted to 61·5%. 257 of 284 (90·5%) patients in the scheduled treatment interruption group reached a viral load less than 50 copies per mL, compared with 134 of 146 (91·8%) in the continued treatment group (difference 1·3%, 95% CI-4·3 to 6·9, p=0·90). No AIDS-defining events occurred. Diarrhoea and neuropathy were more frequent with continuous treatment; candidiasis was more frequent with scheduled treatment interruption. Ten patients (2·3%) had resistance mutations, with no significant differences between groups. Interpretation: Drug savings with scheduled treatment interruption were substantial, and no evidence of increased treatment resistance emerged. Treatment-related adverse events were more frequent with continuous treatment, but low CD4 counts and minor manifestations of HIV infection were more frequent with scheduled treatment interruption. © 2006 Elsevier Ltd. All rights reserved.
ISSN: 01406736
Appears in Collections:Scopus 2006-2010

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