WRONGO! The study was stopped prematurely

WRONGO! The study was stopped prematurely (studius interruptus!?!?), because it was noted that HIVers in the drug-conservation group actually had a higher risk of these oh-so-annoying conditions (including death!) than those in the continuous treatment group! WOWZA, that was a shocker! The take home message was that the increased risk of these conditions was more closely linked to uncontrolled HIV replication than to drug toxicity. We sure didn't see that one coming!

A detailed analysis of all the biomarkers in this study showed markers of inflammation (C-reactive protein, interleukin-6) and a blood coagulation marker (D-dimer) were significantly higher in the patients who were in the intermittent antiretroviral arm of the study. Stay with me; I know this is a bit complicated! (We immunologists just love the uber-complexities of life and death. Yeah, I know we're weird, but hey, we wind up figuring out really cool and scary stuff like the mechanisms responsible for HIV's grow-old-quick trick!) So what we learned from the SMART trial is that ongoing HIV-induced inflammation and a procoagulant state (increased risk of forming blood clots) underlie the increased risk of non-AIDS-related events observed in us HIVers and that in turn accounts for our increased mortality!

So AIDS: Acquired Immunodeficiency Syndrome may wind up being AIDS: Acquired Inflammatory Disease Syndrome!!!

The San Francisco Department of Health has recently become the first to recommend that all HIV-infected people be treated immediately with combination antiretroviral drug therapy without regard to CD4 count or HIV plasma viral load. This is a dramatic policy shift from previous recommendations and published guidelines that advised delaying antiretroviral therapy until CD4 counts had fallen into a certain range. The impetus for the policy shift is the concept of "inflammaging" supported by clinical trials, such as the SMART trial discussed above.