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Clinical trial for newly HIV+
Jan 19, 2007

I recently tested positive two months ago. My Dr. is recommending a clinical trial that has a new drug called elvucitabine. My CD4 count is 346, viral load 30200. I'm 48 and healthy with no symptons. I'm concerned its my 1st time with meds and that the drug is still in trials. I'm worried over complications and that the new drug could potentially limit future options. Do you have any guidance to help make the decision?

Response from Dr. Pierone

Hello, and thanks for posting.

I think it is helpful to conceptually divide HIV clinical trials into 2 categories - self-serving and altruistic. Here are two trial examples to illustrate the differences:

A contemporary example of a self-serving trial would be participation in the Merck expanded access program for MK-0518. A person with multi-drug resistant virus and limited treatment options might seek out a study like this in order to get access to this medication to incorporate into a salvage regimen. Although the drug is investigational, and the sponsor will accumulate safety information, the primary study objective is increase the chance of survival for someone in trouble.

An altruistic study is one in which the participant puts himself or herself at some degree of risk in order to help advance understanding and treatment of HIV infection for the benefit of the community at large. The study you were offered fits into this category and your concerns about potential toxicity and resistance issues are justified. By the nature of investigative studies, it is difficult to predict how risky (or not) a new medication or approach may be. But your doctor should be able to give you a general sense of how far away this study is from standard care.

There are blended examples in which the study is altruistic in nature, but also provides some tangible benefits for the participant. An example would be a trial which involves the potential risk of a new antiretroviral, but includes the benefit of paying for labs, clinician visits, and HIV medications for the duration of the study.

Clearly, clinical trials are essential for advancement of science and human health. Our team is actively involved in many types of research and so we are part of this investigative infrastructure. But the decision to participate should be based on the merits of the trial and the risk tolerance of the person considering involvement.

Let us know how things turn out and best of luck!



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