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clinical trial ?
Feb 24, 2005

Thanks again for a great website! It has been so helpful for myself, partner and family. I wrote in once before and asked if starting treatment with a VL of 100,000 and t cell count of 515 was recommended knowing that acute HIV infection was just within the last two months. Infected last November. Your advice was to wait for next set up labs which I just had drawn. I am anticipating, hoping that VL is down a little, maybe 60,000 and tcells up a bit. My set point is not yet sure as acute infection was recent. My follow up question is this: I have the opportunity to do a clinical study. It would be a 10 day monotherapy trial of the new integrase inhibitor. Phase II of the study would be more complicated and for 48 weeks - on integrase and others ARVs in comparative study. I'm more curious about your thoughts regarding phase I, the 10 days of monotherapy. Say that my VL is 50,000 and tcells are 600 when my labs come in. What do you know about integrase, not that anyone knows that much? Is it reasonable to think that doing a 10 day trial could bring me down to undetectable and then stay off meds for months to years. Or would I be better off just staying off for now altogether. I know this question is complicated and may be too complex to answer simply. I also know that these are very individual decisions and since this is not an FDA approved drug.. you may not even be able to comment. Any thoughts? THANKS very much for all you guys do! JH

Response from Dr. Pierone

Hi, and thanks for posting.

Phase 1 trials are a crucial step in getting new agents evaluated. But one should clearly understand that participation is a study like the one you describe is not going to result in long-term benefit. Ten days of exposure to a single agent simply does not impact the natural history of HIV infection. So participation in this study must be based on an altruistic motive to potentially expand treatment options for the community at large. The risk might include unknown toxicity or rapid development of resistance to this single agent that might limit the effectiveness of integrase inhibitors in the future. But if resistance does develop in a short 10 day interval it would seem unlikely that the drug is ever going to make it to clinical care.

The follow up 1 year study is a bit different since this could very well impact long-term outcomes. One risk is that you have a high CD4 count and treatment at this level does not have proven benefit (although it is not unreasonable to assume that is might have considerable benefit). Another risk is that marketed therapies have high success rates for initial treatment and you would be on an unknown combination that may well be more toxic and less effective than standard of care. Or it could turn out that this new agent represents an advance in therapy, no way to know at this point. But again, this is a study one does to advance science and hopefully increase the range of options for all HIV-infected patients. This is a very worthy goal that requires careful consideration.



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