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clinical trial ?
Mar 13, 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 T cells 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 a 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 T cells 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. Conway

Thank you for your kind comments about the site.

As for whether you should go on treatment at all, this is an individual decision. The reasons you may consider going on medications in the setting of acute HIV infection is with the hope that you may only have to take HAART for a certain period of time (perhaps one year) and that your body will be able to handle the virus after that. The down sides are the risk of side effects and the possibility that your virus may become resistant to the drugs used to treat it. The resistance thing is quite unlikely if you are adherent to therapy.

It doesn't really matter which HAART you take to accomplish this goal. The 10 days of integrase inhibitor monotherapy will NOT make you undetectable. The subsequent 48 weeks of therapy will be needed to do this. The information that will be gathered from the first 10 days will help in the design of future studies of the new drug, and may not necessarily be of benefit to you. So if you do this, you are doing it to help others that will follow you. You, in turn, will be helped by the treatment that you will then take.

First, decide if you want treatment or not. If you do and you also want to help advance research, then go for the study.

I wish you good luck and success whichever way you go...



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