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Trial
Jul 21, 2006

I was enrolled in the Pfizer ccr5 study and my numbers seemed to respond to the drug. Pfizers labs showed that sometime during the study I converted from single tropic to duo tropic and told me they would not continue giving me the drug since in their words I was a drug failure. My VL dropped from 160,000 to 30,000 and CD4 went from 90 to 159. There were differences with their labs and my regular lab results.

Now Pfizer wants more blood as an exit sample and the return of the containers and I am refusing.

I feel great on their drug and my argument is that if I am doing well on the trial, why not just give me open label. They have refused to do that.

Are the drug companies skewing the results of the trials to make sure they get the results they want, I think they are. Now I have to use another bullet by changing to another drug TMC114. Is this something you have found to be the case where a drug company can take my blood for 9 months, not like the results, and then just throw me out of the study. Seems they are messing with my life, but I should remember they are in it for the money not to help the patients.

Response from Dr. Daar

I am sorry that your experience in this trial has been so frustrating. I do not know the specifics regarding the trial you are involved in but I do know about the drug being studied and some of the unique issues surrounding the development of this novel class of antivirals.

First of all, it is important for you to know that every study is unique. In addition, how different scenarios are dealt with in any given trial is generally agreed upon in advance in order to minimize any bias. Please do not think that your contribution to this study is not relevant now that your participation will have ended. In reality, your results will be included in the study analysis and you will likely reflect a treatment failure which is not good for the drug or the company developing it. What is unique about this particular drug is that it blocks a specific receptor on the cell, CCR5. One of the concerns about using this drug is that the virus might switch to using another receptor, CXCR4. The reason for this concern is that there is some evidence that those who have viruses that use CXCR4 may do worse than those that do not. It is for this reason that the company is following you and others for the development of CXCR4 utilizing viruses while on treatment. It is because we do not know the consequences of this switch that the study was designed so that those found to switch are to have study drug stopped. These issues are all in place to minimize the risk to study volunteers.

An extremely important question that must emerge from this study is what are the consequences of developing a CXCR4-utilizing virus. It is for this reason that I would strongly encourage you to continue study visits as outlined by the protocol. I know that this doesn't seem fair but it really does make sense in the design of this study and it is vital that people like you be followed, even off drug in order for this potentially important class of drugs to safely move forward.

I hope this makes sense and is of some help. Thank you very much for your participation in clinical research. If not for people like you we would not be in the position we are in today with highly effected antiretroviral therapy. You have made an enormous contribution and difference as a result of your enrollment in this study.

Best, Eric


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