The Thursday Night Weekly Health Care Series is published every Thursday. It is meant to provide a forum and encouragement for people organizing for positive health care change.
So, today marked the half-way point of me successfully completing my first real HIV Clinical Trial.
7 days down, 7 more to go.
I would be a liar if I did not own up to the fact that while in part my being enrolled in this clinical trial is because of altruism, part of it is pure selfishness. I want to remain healthy.
More after the fold including pictures!
First, a little history about how I got to this place.
In February 2006, I successfully completed a 78-week regimen of pegylated interferon for my Hepatitis C infection. This was the second round of interferonI had done, the first unsuccessfully ending after 40 weeks.
The great news was, as many of you may remember, is that I cleared Hep C and am for all intents and purposes, as of September 2006, cured of my Hep C infection.
During the course of my second round of interferon, which was really a debilitating experience physically, we noted that my HIV meds were not responding very well and that my HIV viral load was still not in the "undetectable" range. Not by a long shot.
Three times during the past three years, in fact, we have changed my HIV meds in the hope of finding a combination that would both work and be tolerated by my body. Once and only once did I ever hear those magic words that I had an undetectable HIV viral load. Once. The next time we drew my labs, I had detectable viral load again.
Needless to say, this frustrated my primary care doctor to no end. Her frustration level was a mere fraction of my own.
We did everything -- ran tests for resistance, for mutations, for everything. I was sent to specialist after specialist who found nothing wrong with me and/or that could explain why my meds were not working. My gastroenterologist said, rather matter-of-factly, that my inability to absorb my meds was just a case "...of HIV disease progression..."
And that scared the hell out of me. The truth is that I started taking HIV meds in 1990. AZT. As monotherapy. I remember when "combination therapy" meant taking AZT and one other drug (in my case it was ddC). So to hear ""...disease progression..." resurrected all the images and realities of mine having lived through both the worst of HIV drug times (when there were NONE) to when there was one to when it was more promising (with marginally-beneficial to significantly-beneficial newer classes of HIV drugs) to now.
Recognizing the fact that I would have to make yet another change in my HIV regimen, my primary care doctor decided that a reasonable bridge between the current regimen and the next might be for me to see if there were any clinical trials in the area that might be good for me to enroll in or to see if any were coming down the pike.
My doctor then gave me a phone number to call. It was for a local research site that she had the utmost trust in who did HIV clinical trials. One phone call later, I was on the phone with the physician who ran this clinical trial research site.
He immediately noted that a drug was about to be in clinical trials which seemed perfect for me and my predicament. I was told I'd hear back from him in about two weeks time and we would go from there.
A week later, I was called by the research site physician with the bad news -- the drug that he thought I would be a good candidate for was being delayed for about 6 months. But, in the meantime, there was a drug that was in clinical trials now that he thought I could be of some help to HIM with. Would I be interested in being in that trial (pending me qualifying for it, etc.)?
Without hesitating I said I would. For me, the altruism here seemed to balance out the practical side of the equation -- if I was able to get into the system (so to speak) with the one drug that they needed volunteers for, the ease of me entering into the clinical trial for the drug that we thought would be good for me would be all the more facilitated.
This is not to suggest that the drug that I am taking now in the clinical trial is not without possible benefit for me. Far from it. I happen to fit the profile of the type of HIV individual the drug trial needs now as it moves through its clinical trial phases. The drug had shown itself safe and effective. At this juncture, they needed to have a bevy of HIV positive individuals on a stable HIV treatment regimen (regardless of how good or successful the current regimen) to now take this drug in addition to their current regimen of drugs to note if it works (and I am paraphrasing very badly here so forgive my shorthand) better or not better in HIV positive individuals with a specified mutation or point mutation in their T-cell.
The exact science of the drug that I am taking, known as bevirimat,can be found herein a journal/trade article from 2006 or even better, by just going to page 35 of this pdf file of that journal itself.
In a nutshell, the drug I am taking now is a Maturation Inhibitor, which means it basically renders the HIV that buds OUT of the T-cell to be non-infectious and further replication is terminated. That is what the drug is supposed to do.
The beauty of this clinical trial is that it lasts just fourteen days. Yes, I wrote that correctly, just two weeks. So, what has my last seven days been like?
Here is where I thought pictures might be helpful, if not just a way to break the monotony of my typing this all out...
Everyday I go to the clinical trial research site at about the same time. I get my blood pressure and pulse recorded and then I get blood drawn. EVERY DAY (except for the four days that fall on the weekend). Yes, 10 days of blood draws.
The majority of days the blood draw is just three vials, like today:
However, a few days we have to draw upwards of 10 vials of blood. Not for the faint of heart or for those who hate having their blood drawn, that is for certain!
After the labs have been drawn, then comes the time to take the actual medicine.
Because of the juncture of this drug in its trajectory, there is no placebo; I am taking bevirimat.
The drug comes in a cough-syrup-like bottle like so:
The bottle is about 50% full, as you can see here:
After I drink the drug, I then have to swish out the bottle three times with water and drink that -- I guess to guarantee that I get as much if not all the drug as possible from the bottle. When I am done, it all looks like this (this photo I know is kind of gratuitous but I like how this photo signifies completion):
So it has been seven days now. How do I feel? Apart from feeling (sometimes quite) fatigued, I feel fine. I realize that i am only half-way done and I can't project or extrapolate any more than what I just have.
Am I nervous or excited or anxious?
Hell yes, all of the above.
Is it working?
I do not know.
When I know something, I will certainly let everyone else know what I do. Until then, I am just part and parcel of the process for the time being.
That they have been taking my blood every day (save for the weekends of course) means we now have a running account of my HIV viral load for the weekdays that i have been on the drug. if this drug is having any impact on my absorption problem, we will know very, very soon.
Plus it will also show us how the drug has impacted my other blood levels on a daily basis, which I find rather fascinating, although a bit detached...
I have to fast for at least two hours before I take the dose every day. I have diabetes, which means, for those out there who also have diabetes and do the 5 meal-a-day routine as part of their diabetes management, I have to get up at the crack of dawn to eat my first meal of the day and take my metformin (the drug I take for my diabetes) and all has to be done at least 2 hours before my dose of the clinical trail drug.
So every morning around 6:30/7:00 a.m. I am waddling around the kitchen making my oatmeal and taking my HIV meds and my metformin and eating meal number 1. This also means that when I get home from the research site that I have to eat meal number 2 right away so that I can stay on schedule for the normal 5-meal-a-day plan.
Luckily, my current HIV regimen is a twice-a-day regimen, a bunch of pills in the morning and then a bunch of pills at night. The only drug that breaks from this pattern is the drug I take for my HIV-related peripheral neuropathywhich I have to take 3 times a day.
And that's just about exactly where I am right now.
I wanted to write this diary as part of this on-going series of health care diaries because I think it is critical for those of us who are engaged actively in the system as patients, as subjects, as consumers (for lack of a better word -- I agree that the word consumer is far too commodified but...) personalize this series, give it a real, human dimension.
The face that is behind the brilliant diaries in this series that are advocating for better, more comprehensive, more realistic , more flexible, more humane health policies etc. is mine.
And so it is only fair that you know what I am going through and experiencing if I am to hope that you'll help make my health care system a better one.
And not just for me, but of course, for me all the same.
UPDATE: Just wanted to be clear that the clinical trial I am in does not cost me anything other than the time and the time commitment that I have made in order to be in it. For individuals who find themselves in a similar boat as me -- with treatment options being limited or at odds -- looking into clinical trials is a possibility. And one that may be well prove a worthwhile investment.