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Study group, please help.
Apr 21, 2007

I went to my ID for my follow up appointment yesterday. Second set of labs showed CD4 294, VL 40000. Genotype showed no resistance to any of the current meds. I was then asked if I wanted to be part of a study group that is taking 500 people just starting treatment that have never had any meds. The treatment would consist of Epzicom, Norivir and Reyataz. It was explained to me that the Norivir acts as a boost to the Reyataz. Also they would need to run work on my blood to see if I could possibly have a reaction to the Ziagen in the Epzicom. It would be very closely monitored but at the 32 week mark some participants will have the Norivir taken out of the combination , the reason being is they say the boost is no longer necessary and Norivir has shown to mess with lipid levels in the blood.

My fear is not really the medications as they have been proven to work but the amount of time the screening would take to finally starting on meds. If i decided to go with it I would go in for screening they would run the blood work and then it would be a month before anything would happen. I am newly diagnosed and quite scared, my mind thinks thats another month for the virus to grab hold and lower things to the possibility of an OI and end up hospitalized. I am newly diagnosed March 26, my head still hasn't gotten a firm hold on things and in a way I feel like they looked at my charts and no longer saw a person but a guinea pig. Pluses would be no Co Pays, no med costs, and they would pay me for every visit (which seems to be quite a few) I have good insurance (15 visit co pay)(5 med co pay)and make a decent living so the money really doesn't entice me. Besides if I lose my job I would be off the study as I couldn't afford the insurance on my own.

I don't know what to do, please help me. Does this sound beneficial? Is it wise for me to wait another month before doing anything? I know ultimately the decision will be mine but the input I get from the reponses here really help me out. Thank you Dan

Response from Dr. Young

Thanks for your post, Dan.

This commentary will undoubtedly have the potential to be biased (our clinic in Denver is also participating in the study and I'm assisting with the analysis), but the first and most important aspect to your question is when to start treatment and the risks of study participation.

It's very rarely an emergency to start medications for HIV- indeed, even for those persons with active AIDS complications, most experts would wait at least a couple of weeks to intiate treatment. With your CD4 count of around 300, you're at very low risk of having an AIDS complication in the short term. It's a very valuable time to get a lot of things in order- I'm happy to hear that your doctor has done genetic (resistance) testing on your virus, one fo the things this study would like to clarify is the role of genetic testing on you to see if you're at risk (or not) of developing an allergic reaction to one of the study medications (abacavir). Other smaller studies from Australia and Europe have shown that among persons who test negative for the genetic marker, the risk of the reaction is very, very low. The study involves a combination of HIV medications that is currently listed as an alternative one by US Department of Health and Human Services and is on the recommended list by the International AIDS Society- all of the medications are FDA approved; as such your risk in this study is far lower than other studies of non-FDA approved drugs.

The 2-3 weeks it would take to go through study screening and to start on study medications shouldn't place you at significant health risk. You've otherwise summed up many of the pros and cons of study participation. In my view, patients who enroll in studies (any studies, not just this one) seem to actually get more careful monitoring about all those things that matter- medication instructions, side effects, potency of medications.

All of us in the HIV community are grateful for the many thousands who have participated in clinical trials. Without them, we wouldn't have today's treatments for HIV. To this end, thanks for thinking about study participation.

Write back anytime if I (we) can be of help. BY



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