Friday, December 17, 2010

'It's inside you now.'

She slid the needle out of my forearm and pressed a cotton ball in firmly. A tiny red bubble leaked out before she reached it. The cotton slurped it up.

"It's inside you now," she said.

I shuddered. I had not expected a remark like that, or the fleeting panic it set off.

I had just enrolled in an HIV vaccine study. It was a Phase III trial, overseen by the NIH and CDC, which meant it had already proven safenow we were proving efficacy. WeI liked that. Except we were disproving efficacy, more likely.

The consent form ran more than twenty pages. I read every line. I needed to be sure. My counselor was thorough, knowledgeable and caring. She was not letting me sign until I demonstrated I understood all the risks. Honestly though, they were minimal. I really wasn't worried at all.

Until she injected that first dose into my vein. And muttered the obvious.

God. Something was alive inside me. Tiny strands of DNA were making their way up my arm, toward my heart, to be pumped through every living tissue in my body. The DNA was manufactured synthetically, but identical in outward appearance to the deadly virus. Close enough to fool my body, hopefully. But inert, so it wouldn't kill me.

The side effects, if I had any, were due within 48 hours. Possibilities included nausea, mild fever, and a sore throat. Those were signals my immune system had ramped into overdrive. My throat would ache because the lymph nodes there had swollen to full capacity to pump out killer T-cells and macrophages to battle some disturbing invasion. All-out war raging inside my bloodstream.

How much of that shit had they injected? Enough to scare the hell out of my immune system. They hoped. Enough to prepare my body for the real virus a year or two or ten down the road if I did something really stupid.

It failed. That first injection was ten years ago, at Denver Health Medical Center. AidsVax was the most promising AIDS vaccine ever, the first to reach Phase III. I spent three years in the study, got a fresh injection and a free HIV test and a lot of counseling every six months. In February 2003, two decades into the search for a vaccine, VaxGen, the company that had developed the concoction announced its results. No statistical impact.

Today, Kiwan, a very professional counselor at Project Achieve in the East Village in New York City, slipped a fresh needle into my arm.
No vaccine yet: this was my first visit, and I'm still being vetted. She took a blood sample to check for prior exposure to a certain cold virus. If I've had that cold, I'm out.

This new trial is testing two different vaccines in combination. One of them uses a common cold virus as a delivery vector. For complicated reasons, a previous vaccine study indicated there might be a slight increased risk for contracting HIV if my body already created antibodies to this specific cold. It may well have been a statistical anomaly, and there may be no relationship whatsoever, but just in case, they are excluding people who have had the cold, for our own safety. I appreciate that.

I'll also be out if it turns out I got the actual vaccine in the VaxGen trial. It was a double-blind study, with one-third of us getting a placebo. They were supposed to tell me which group I was in when it was over, and I think they did, I just can't remember. That seems odd. I have this inkling that I turned out to be placebo, but . . . it's foggy. I saw the news accounts of the failure weeks earlier, so it was moot by then anyway. If my body had mounted a defense from those injections, it was futile.

If I don't qualify for this study, there will be more. Unfortunately. This afternoon, my counselor mentioned that there were now several vaccine trials in progress simultaneously. Mine was called 505. "That's basically just the next available number," she said.

"Wow," I said. "That's how many they've tried now?"

"I guess so."

"Five hundred four failures. Yow."*

I already know this vaccine won't prevent infection. Or if it does, I'll play not even a bit part in determining that. They are not even trying to evaluate prevention in this study. Researchers are going after AIDS every way they can think of, and this approach is to pre-condition my body so that if it is infected, it will fight the virus more effectively.

Huh. What a sobering goal. Not so glamorous to be a part of that project. A non-cure. Just something to lessen the damage.

Well . . . I thought about it a second. Did I really want to bother?

Yes. Yes, of course. Millions of people will be infected with HIV. If this thing works, and it prevents half or a quarter or whatever fraction of those millions from progressing all the way to sickness and death . . . that's damn good, too.

I also learned that the 504 accomplished something after all. This studythis whole strategy to attack the virusgrew out those "failures." We learned a great deal.

And we learned they were truly safe. VaxGen was the first large trial (I think the first to include thousands of human lab rats.) Conceptually, it was safe, now we have hundreds of thousands of subjects like me from a multitude of similar studies walking around healthy to prove it.

This time, I had to force myself through the consent form. They know what they're doing. I don't foresee even mild fear.

Some other group is searching for a true preventive. Someone is working on a cure. And then there's my group, should I be accepted. I had no idea until this afternoon that someone was working this strategy. I was glad to learn they are. And to play an itty bitty part to help them.

You can too. Oh, surely you saw the pitch coming. You might be scared the first time they inject you. I was. It passed. It was replaced, quickly, by the fear that I'd feel invincible with this promising new body armor possibly sealing me off from AIDS from the inside. That's a whole nother story, which I'll tell another day.

It's moot now. Nobody is that hopeful anymore. HIV is one wily organism, and the chance of outsmarting it with any particular agent is low. That's why we have to try more than five hundred times.

Project Achieve is part of the HIV Vaccine Trials Network (HVTN).  That's their logo up there. "Hope takes action," it says. They've got a point. Millions of people are dying. I've been hoping for an end to the scourge more than half my life. Hope isn't enough. Somebody has to do something. That can be you.

It's not hard, or risky, and it's only scary a little while.

If you're male, 18-50 and HIV-negative, you're eligible for this trial. (I don't think you have to be gay, but you might have to be sexually active. I'll find out.) Other trials have different criteria. HVTN is running trials in 27 cities on four continents (including Africa and South America).

If you live in New York, LA, Chicago, Seattle, San Francisco, Atlanta, Birmingham, Nashville, DC, Philadelphia, Boston, or Rochester, there is a site near you, and it needs your help.

My counselor also handed me $50 when I left, and a subway card with two fares. That was unexpected, but nice. You're not going to get rich off the study, but every visit, they pay you something for your time.

Think about it. Better yet, talk to someone. Click on any city here for contact info in your town. Or call 1-800-448-0440.

Someday, there will be a cure. Help make it sooner.

___

* All quotes are from memory. They are close. I'm sure they're not exact. The first one, in the title, was quite awhile ago, but it's been rattling inside me the whole time.

Since I'm making author's notes, yes "nother" is a word. People use it every day. Listen.

Update, Jan 7:

Well, I learned this week that I was indeed indeed in the vaccine pool last time. My coordinator hoped that it was long enough ago that I could participate again, but the word came back noand that I probably never can again.

Drat. (Although who knows. Maybe someone will do a study, or include a cohort, on people with prior vaccine exposure. Probably not, though.)

I'm going to see if there's some other way I can participate. It's important, folks. And it's really quite easy. Please consider checking into it. Thanks.

11 comments:

  1. While "nother" is perhaps a quasi-acceptable colloquialism, the appearance of "it's" where I expect to find "its" in your blog is really beneath you. Come on, Dave, you're supposed to be a professional writer to whom kids look up. Get it together! To that end, as a professional, you shouldn't defend colloquialisms in your work.

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  2. Anon, haha. Thanks. That was my first reaction, too. I admire your brevity, but lack that discipline. Here's what I was just typing up:

    Thanks for pointing out a typo, Bob--even if you didn't bother to point out where it was. I fixed it.

    But really, that's your primary reaction to that piece? A typo? God, I pray you're not an English teacher. It's that myopic focus on the trivial that drives so many kid away from writing, and reading. Sad.

    Luckily, I've spent a lot of time in schools this year, and met a ton of great teachers focused on opening up imaginations and inspiring kids to love books. So I'm optimistic despite folks like you.

    Clearly, we also have a different philosophy on colloquialisms--though the basis for yours is unclear, as you don't bother to present it, and go straight to the scold. You know best.

    ---

    FYI to everyone: I do appreciate you guys pointing out typos. I like to fix those. The indignity, I can live without.

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  3. Hey, I've gotten a lot of comments about this on Facebook, and now I wish I'd included this from FYI, from the Project Achieve FAQ, just to put the whole effort in perspective:

    "It took 22 years to find the vaccine for Hepatitis A. 30 years for the Measles.

    We are approaching the 20-year mark of working on the HIV vaccine. It may seem like a long time but the Polio vaccine took 47 years."

    http://nycvaccine.org/faq.php?l=faq

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  4. I am a type 1 diabetic, and I regularly participate in diabetes studies through my doctor's office in Denver. I hope your post will encourage more people to participate in medical studies. It really is rewarding, and the extra money (and, in my case, free insulin and supplies) is a nice bonus.

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  5. As an English teacher and a fellow author, I would say that Bob has no grasp of voice. As for occasional stray apostrophes, that's why I grade content and mechanics separately (and thank God for copy editors). The piece is powerful. I have known good people who died of AIDS, and I admire your willingness to put yourself out there to help stop its (no apostrophe) spread.

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  6. Great post, Dave. I've linked to it on the 505 study's Facebook page (HIV Vaccine Trials Network).

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  7. Cheryl, thank you. I hope it helps in some tiny way.

    And I like that logo you have at the site.

    Here's the link for anyone who wants to Like it on FB:

    http://www.facebook.com/pages/HIV-Vaccine-Trials-Network/55636956839?ref=ts&v=wall

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  8. Dave:

    Great post. I have just wrapped up a year of being a participant in a different version of a similar study and have been blogging that as well. I was taken by your mention of the fleeting panic that followed her saying to you that it was "in your now" because I remember that moment so well myself and how quickly that turns into pride.

    Good luck to your in your study. My blog can be found at: http://web.me.com/aprislovsky/andrewsadventure/Overview.html

    Best,
    Andrew

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  9. Thanks, Andrew. I'll check it out.

    I didn't really ever get to the pride stage, but I did get past the fear pretty quickly.

    And the study really helped keep me in check. Knowing I had to confess anything stupid I might do helped keep me from doing it.

    And it was nice to have an expert to pose questions to as things came up. At one point, I got into a serious monogamous relationship, and I was afraid having unprotected sex together after we waited and got tested would be frowned upon. But my counselor said that if I trusted him, that was great: "the gift of monogamy," she called it. I can't tell you how much comfort that gave me. (Until we broke up. Haha.)

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