An Interview With Jonathan Li, M.D.
What other subanalyses are you guys planning? Are you planning to look into specific tissues or compartments?
We are not doing any tissue biopsies in this particular study.
So, not a horribly invasive study for the volunteers.
Exactly. It's already a little bit difficult to -- involvement has been a little bit slower than we had hoped. We knew that that would be a concern: These patients had been told for years and years and years that they don't need treatment, ever. And to try to change their thinking a little bit, or to make them aware that therapy might be beneficial, takes some education and some convincing.
Not only that, but you clearly are an empathetic human, and it is not unrealistic to think that not everybody is going to be like Timothy Brown, and be willing to be poked and prodded to the ends of the Earth. So it's understandable.
Absolutely. I completely agree. But we are going to be doing everything we can with the blood, in terms of looking at T-cell activation, various cellular activation, markers of systemic inflammation. We're going to try to look through all these different cell populations to see where HIV might be hiding, and whether or not it will enhance the regeneration of T cells, the use of alternative therapy.
We'll be looking at quality of life in patients, as well.
Can you be more specific about what you mean by quality of life?
Patients are getting a questionnaire to see whether they have side effects. Sometimes, for non-controllers, when they take treatment there will be some side effects associated with that. That's part of what we're trying to figure out: How bad the side effects affect them.
But also, some of my patients, at least, feel better on treatment. It's not that necessarily they weren't feeling -- you know, that they had this baseline of health that they were used to that they didn't realize was necessarily abnormal. But on treatment, these patients actually felt a little more energy, a little bit better.
We want to look at how difficult is it for these patients to take [treatment]. Are there any side effects that are really affecting their life? Or are they not having any problems with these medications?
How are you going to be measuring adherence?
During the initial part of the study, there's a viral decay component for a subset of patients. But for those patients, they'll be getting an adherence journal to be taken home to fill out what time of day that they're taking the medications. Otherwise, when they're coming in for their visits there's a questionnaire to ask them about adherence.
OK. But no intensive pill bottle counting or electronic tracking?
Why 57 patients for target enrollment? What makes 57 a magic number?
It's a balance between the numbers that we think that we can realistically enroll, as well as a statistical analysis of what makes sense, in terms of powering the study for being able to see a difference in the T-cell activation.
Myles Helfand is the editorial director of TheBody.com and TheBodyPRO.com.
Follow Myles on Twitter: @MylesatTheBody.
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