JAC Advance Access originally published online on February 4, 2004
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Journal of Antimicrobial Chemotherapy (2004) 53, 501-505
© 2004 The British Society for Antimicrobial Chemotherapy
A randomized trial to investigate the recycling of stavudine and didanosine with and without hydroxyurea in salvage therapy (RESTART)
The St Stephen’s Centre, The Chelsea and Westminster Hospital, London, UK
Received 22 October 2003; revised 9 December 203; accepted 12 December 2003
Background: Treatment failure during highly active antiretroviral therapy (HAART) is ultimately common and associated with the development of resistance mutations to both the specific drug in question and cross-resistance to other available treatment options. In heavily pre-treated patients, the recycling of antiretroviral agents that have been utilized previously may, however, be associated with antiviral efficacy. We therefore conducted an investigation into the concept of recycling stavudine (d4T, Zerit) and didanosine (ddI, Videx) with and without hydroxyurea, in the management of heavily pre-treated HIV-1 infected individuals requiring salvage therapy (RESTART).
Methods: We randomized 21 individuals with treatment failure to receive stavudine and didanosine or stavudine, didanosine and hydroxyurea, for 12 weeks prior to optimizing therapy. Viral load, immunological parameters, genotypic information and the virtual phenotypes were obtained at baseline and at the end of the study.
Results: Significant decreases in viral loads were observed in both groups during a 12 week study period (P = 0.04), the addition of hydroxyurea conferring no additional benefit. This was not predicted by information from genotypes and virtual phenotypes, and these did not reveal sensitive or specific phenotypic cut-offs for those individuals who responded to recycling.
Conclusions: Salvage therapy with didanosine and stavudine can decrease viral loads in heavily pre-treated individuals. Genotypic and virtual phenotype profiles provide little additional information in this setting.
Keywords: recycling, phenotype, nucleoside analogues, HAART
* Correspondence address. Department of Immunology, The Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK. Tel: +44-208-746-8251; Fax: +44-208-746-5997; E-mail: j.stebbing{at}imperial.ac.uk
A. P. and B. G. are joint last authors.
¶ A. P. and B. G. are joint last authors.
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