Publication:
CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial

Issued Date

2006-08-05

Resource Type

Article

ISSN

01406736

DOI

10.1016/S0140-6736(06)69153-8

Other identifier(s)

2-s2.0-33746479812

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Lancet. Vol.368, No.9534 (2006), 459-465

Suggested Citation

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 CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial. Lancet. Vol.368, No.9534 (2006), 459-465. doi:10.1016/S0140-6736(06)69153-8 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/23644

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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

Author(s)

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

Other Contributor(s)

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

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 ClinicalTrials.gov 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.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/23644

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Scopus 2006-2010