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The Smart Study: wishy-washy research?
May 3, 2009

What other factors, besides stopping the meds treatment, were taken into account(tracked)during this research with regard to the patients' lifestyles? First off, how were patients taken off the meds regimen: were they weened off or were the meds stopped abruptly? Were other behavioral factors tracked such as use of nicotine/recreational drugs, type of nutrition/diet, excercise or no excercise, sex/no sex activity(would masturbation be considered one or the other?), use of vitamins/dietary supplements, use of alternative/holistic therapies(massage, herbs)and other possible factors I can't think of. I've not come across any discussion of these factors while reading up on the Smart Study. Were any of those factors taken into consideration during the process. And if not, why not? Further, the conclusion that deaths caused by those who had stopped treatment were not due to HIV opportunistic infections even with rising viral loads and lowered CD4 counts seems puzzling w/o satisfactory follow-up statement.

Response from Dr. Young

Hello and thanks for your post.

First, some bias. Our clinic was a participant in the SMART study (though I was not part of the investigative or analytic team).

The SMART study was one of the largest, randomized studies of HIV treatment in history. The study was not aimed at looking at behavioral factors that you've listed, but rather to examine the strategy of continuous versus interrupted therapy. Because of the randomized nature and sample size of the study, many demographic and behavioral factors tended to be well balanced between the two study groups. Thus, any differences between the two groups were likely due to the interruption (or continuation) of antiretroviral therapy, rather than other variables (such as the ones that you're interested in) that were equally represented in both study groups. As for your specifics, I'd doubt that massage or masturbation would have any significant effect on complications from HIV.

As for the causes of death, it was indeed interesting that there were more deaths in the interruption group; causes that were both HIV- and non-HIV-related. The major results of the study were published in the New England Journal of Medicine in 2006; there have been many subsequent presentations from the investigative team.

Wishy-washy? I think not.

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