January 15, 2013
Nelson Vergel, B.S.Ch.E., M.B.A., is a leading HIV treatment advocate, author and founder of the Body Positive Wellness Center in Houston, Texas.
I guess you're thinking about proceeding with human pilot studies, too. How is that going to happen?
I've already spoken with officials at the NIH [U.S. National Institutes of Health] as well, and to physicians who specialize in viral eradication. They're trying everything but the kitchen sink. The fact that this drug is already approved and under controlled conditions, we're planning to do a carefully designed clinical study. We want to do this in monkeys first as a proof-of-concept, but I think there's enough interest among some of the physicians I've talked to to perhaps do a small pilot study and see whether indeed this works the way it's supposed to. This is all very new stuff. So we're gearing up toward that and we hope that we will get our protocol approved so we can actually try it in humans.
It's also a question of getting some funding for that study, but it's a small number of patients because it's a high risk, high return and I don't think the drug on its own is going to be enough. We need to basically find patients who are already virus suppressed on HAART and add on this molecule for a few months and eventually take off the other medication and see what happens; see if the virus gets reactivated or reactivation is delayed. You have to select very carefully the population of patients that you're going to use for the study; they shouldn't be very sick and we have to be careful, because resistance could be an issue, especially in patients who've had HIV for a long time. So you don't want to withdraw treatment unnecessarily. The patients have to be monitored very carefully. We also have to develop better methods for detecting virus at very low levels. It's something that we can do now with the technology available for that purpose. That's why I wanted to do this in monkeys first, but as I said, some of my colleagues indeed would like to go straight into humans.
Will the funding come from the NIH or from any of the companies like Pfizer? Are they interested in this kind of indication?
I cannot talk, because I have a CDA [confidential disclosure agreement] with the company. I cannot discuss which company. All I can tell you is I'm working with a company at this stage, trying to look at better drugs that would have lower toxicity and be safer to use specifically for this purpose. I don't know whether they have funds for this study. We have other resources and for a pilot study it will not be costly.
This transcript has been edited for clarity.
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