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SMAART Study
Nov 2, 2003

Dr. Pierone, I am close to starting treatment. My Dr. has given me some options of starting regiments, but also asked me to consider the SMAART study. From what I have read, and what I have been told, I take treatment until my CD4's go up to 350, and then they take me off of them. They then monitor me constantly and begin treatment once my CD4's fall below 350 again. I want to do my part, and the thought of not having to deal with meds constantly day in and day out intrigues me, but what are my chances of developing resistance with this method? What is this study showing? I am nervous I will put myself in an unhealthy position. What are your thoughts?

CD4 350, VL 16,000 16

Thank you,

EW

Response from Dr. Pierone

I am an investigator in the SMART study so I am convinced that this is an important study that will provide some important insights about how to best treat HIV infection. However, this study is not for everyone. In order to participate in this study you need to be comfortable with the fact that it is randomized and half of the people go on continuous treatment (standard of care) and the other half go on treatment when the CD4 count drops below 250 and stop when the CD4 count goes above 350.

This is what I refer to as an "altruistic study". This study will advance the knowledge base and help us answer some of the crucial questions of HIV management. But an individual does not need to be in the SMART study to plan some treatment interruptions for the future. You can sit down with your doctor and plan to do periodic treatment interruptions (if he or she agrees). Also, if the prospect of possibly going off therapy and watching your CD4 count drop to 250 scares you, then this is not the study for you. Conversely, if the prospect of continuing treatment with a CD4 count of 900 makes you uncomfortable then you should pass on trial.

I think the risk of developing resistance in the STI arm is going to be very low. My personal belief is that there will be less resistance developing in those on periodic treatment. This is because many people on this arm of the study will have extended periods off therapy and resistance does not develop without selective pressure from the medications. On the other hand, we know that people on continuous therapy for years have challenges with complete adherence and as a result viral resistance is a very common consequence of HIV treatment.

What ever decision you make, best of luck!



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