Important note: Information in this article was accurate in August 2004. The state of the art may have changed since the publication date.
 |
HIV Treatment Bulletin - Vol. 5, No. 7, August/September 2004
The following letter was received from Jens D Lundgren and others
In the July issue of HTB, Simon Collins raised concerns regarding the potential of emergence of resistance in patients discontinuing an NNRTI-based ART regimen, and he was asking for guidelines for how to diminish the risk of this in the SMART study.
The SMART protocol team shares the concerns being expressed in the article. Immediately after the data were first presented at CROI, we drafted a set of guidelines on strategies to diminish this risk.
The preferred strategy is to switch to a PI-based regimen 3 weeks before discontinuation to allow for complete removal of the NNRTI when ART is discontinued. Although this strategy is not based on formal clinical studies, it is the best advice available at the present time. We plan to update the guidelines as new information emerges.
The SMART study plans to enrol and randomise 6,000 patients to one of two strategies of using ART:
The study will proceed for the next 5-7 years and hence allow for a profound understanding of the longer-term implications of the two treatment strategies to be compared. A present, 2,050 of the 6,000 patients have been enrolled, and we expect that a large number of patients from across Europe will enrol in the study over the next year.
Yours sincerely, Jens D. Lundgren & Ulrik B Dragsted (Copenhagen coordinating centre), Adrian Palfreeman, Abdel Babiker & Janet Darbyshire (London coordinating centre).
Comment
The SMART study addresses important and compelling questions over long term management of treatment and has been developed with strong community input and support.
The study protocol for stopping treatment provides current best practice for any patient considering stopping an NNRTI or 3TC-based treatment. As such the guidance is also worth considering for patients stopping treatment for any reason, whether or not they are in this study.
040810
IB040507-29
©2004. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.
