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epzicom truvada,kaletra study
Apr 29, 2006

My brother has agreed to join the study in which he will be given Kaletra,6 pills daily along with either Epzicom or Truvada. He was diagnosed in March with cd4 of 164 & VL 755000. What is this study and do you recommend this? He has great insurance and doesn't need to participate in the study for financial reasons. Please help explain the study. My anxiety is extreme as there is mention that the meds could kill him. Please help. Thank you. Judi

Response from Dr. Young

Judi-

Thanks for your post and caring about your brother's health.

I can't be exactly sure which study your brother has agreed to, but the schema sounds like a very large ongoing clinical trial sponsored by GSK called the HEAT study. This study randomizes patients to receive either tenofovir/FTC (Truvada) or abacavir/3TC (Epzicom) with lopinavir/ritonavir (Kaletra). Both treatment options are among either prefered or alternate regimens as suggested by current US guidelines. I don't have any significant reservations about the use of either set of medications in the hands of experienced HIV treaters. Indeed, the study may help us sort out the relative risks and benefits of the two nuke pairs in a statistically powered way for the first time.

As for your concerns for safety- you allude to the possibility of abacavir allergic reaction-- a reaction that if poorly managed can be very severe (and life threatening). The reaction is many ways is like other drug allergies; nothing to dismiss, but mostly serious upon rechallenge with the allergic medication. In this way, this is very similar to other more-familiar drug allergies (like penicillin and sulfa). The major difference is that the abacavir reaction happens more frequently. For patients who don't develop the reaction, abacavir/3TC has proven to be very well tolerated and effective for a long time. We have many such patients in our clinic.

So overall, I think that the study question and design are sound. I applaud your brother's willingness to participate in the clinical trials process. BY



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