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Drug Naive and Clinical Trials
Oct 6, 2000

I have been recently (1 month) diagnosed with HIV. My Dr. has suggested that I consider a Double-blinded Phase 3 trial for Tenovovir in conjunction with standard drugs. My T-Cells are low at 189 and Viral Load is at 50,000. Should I consider this? or Should I stick to accepted standard treatment. One of my concerns would be to future resistance to drugs in this class.

Response from Dr. Stryker

Clinical trials can be an excellent choice for someone in your position, because they often involve closer monitoring and more complete lab/diagnostic tests than would otherwise be possible for most people. They can also involve earlier access to promising new treatments, or combinations that might offer fewer pills or fewer side effects. However, it is important that you understand the research project thoroughly, as well as the potential risks and benefits, before you start. The following are some general comments that may help.

In any study or trial, there is a research "question", which is to say that something is unknown, and the study is designed to try to address that unknown issue. The question might be, for instance, something like this: "Is Tenofovir (an investigational new drug) in combination with two other already approved HIV drugs as effective, less effective, or more effective than Zerit (an approved and well-studied HIV drug)in combination with the same other two approved drugs?"

Note that one possible answer is that it might prove less effective -- you need to be comfortable with this possibility, as it is inherent to the trial and there is no way to know the answer in advance. This is why trials usually have pretty frequent visits, so that an outcome like that can be picked up early. Of course, it is also possible that the treatment might prove better, or at least as effective. Failure of a drug treatment is possible whether one is in a trial or not, because HIV treatment is still less than perfect. One advantage of a trial is that such problems can be piked up early and addressed promptly.

Phase III trials are for drugs that have already gone through phase I (pre-clinical, safety) and phase II (safety, finding the right dose, and perhaps preliminary efficacy). By this time, it is usually possible to have a sense of how promising and how active the drug is against HIV. It is best to stick with phase III trials that are pretty promising, but what constitutes "promising" is a judgement call to some extent. Most experts consider Tenofovir to be very promising.

Hope this helps. Note that my opinions are likely to be somewhat biased in favor of clinical trials, because much of my work is in that area. You have good options at this point whether you participate in a trial or not; just be sure to discuss any treatment options with your doc in detail. Best of luck. RAS

Rick Stryker, M.D., M.P.H.



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