My Participation in HIV Clinical Research:

Jan 01, 1970

I knew I was officially “over the hill” when I enrolled recently in the AIDS Clinical Trial Group (ACTG) Network’s HAILO study or “Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation.” Talk about sobering up tout de suite. Please pass the prune juice.

The decision to join HAILO was an easy one based on my past experience in an ACTG study right after I learned I was living with HIV in 2006. That study investigated the best highly active antiretroviral therapy or HAART combination for people who had never taken anti-HIV medication. By the time I was diagnosed with HIV just two months before entering the study, the amount of virus in my body had lost any semblance of control. And because I had not been on any anti-HIV drug therapy in the past, I proved a desirable study participant—and certainly a naïve one, in more ways than one.

Truth be told, I didn’t know what hit me when I was diagnosed that summer, and I did my best to educate myself about the HIV and my treatment options. Because my CD4 cell count was so low (54 when I began treatment) and my HIV viral load so high (in the millions of copies when I began treatment) I was told it was unlikely that the viral load would come down on its own. My options were rather limited; I would need to begin a HAART regimen as soon as possible.

And so, after qualifying for ACTG Study A5202, I was assigned a study number and a drug regimen, and over the course of the next seven years my exhaustive lab results and cognitive and physical measurements were tracked and correlated to my study number. And while I was indeed a number—20323234—I never felt like just a number. And from those early days in the study I began developing what is now a longstanding relationship with the ACTG clinicians (led by Paul Sax, MD) in the Infectious Diseases Unit at Boston’s Brigham and Women’s Hospital (BWH). The study physicians and nurses have always been there when I have a question about my meds, my numbers or any health issue that comes up.

They encouraged me not to give up when I became violently ill in the first days after starting the meds back in September 006, even though I was inclined to walk away. I was that ill. The ACTG staff had faith I would turn the corner as the intelligent army of foot soldiers contained in the meds began the difficult task of bringing the extreme levels of the virus under control. They explained I needed to persevere; my condition would improve. “Please just give it a bit more time,” they urged. And the clinicians were spot on—after seven tortuous days the regimen started to work and my health started to rapidly improve.

Just like the ACTG team has been there for me these past seven years, I’m here for them, and I remain dedicated to their relevant, comprehensive and inspired research. That’s why I was so pleased to learn late last year that the National Institute of Allergy and Infectious Diseases had awarded BWH two seven-year grants totaling $140 million, funds targeted for ACTG’s Leadership and Operations Center and Laboratory Center, both based at BWH. At present, ACTG’s primary research at sites throughout the US focuses on an HIV cure, tuberculosis, viral hepatitis, and HIV-inflammation and end-organ disease.

“Results of ACTG trials have helped establish the paradigm for the management of HIV disease and form the basis of current treatment guidelines in the US and internationally,” says Daniel Kuritzkes, MD, Chair and Principal Investigator of the ACTG and Chief of the Division of Infectious Diseases at BWH. “This progress has resulted in dramatic reductions in AIDS mortality across the globe.” In the last seven years alone, ACTG has enrolled more than 25,000 participants in 85 clinical trials in the US and in resource-limited settings around the world, and has made significant progress in advancing specific uses of HAART and ART.

I happen to know firsthand how accurate Dr. Kuritzkes’ comments are about ACTG trials guiding HIV medication regimens. When I started the HAART study in 2006, I was assigned to the Reyataz (atazanavir sulfate), Norvir (ritonavir), and Epzicom (abacavir) arm of the study, although I did not know if I was taking Epzicom or Truvada (tenofovir). And then a funny thing happened after several successful years of sustained undetectable viral load and even though I never missed a single day’s dose, my viral load started to spike well above the undetectable threshold. Because data was still being pulled from study sites across the US, ACTG researchers were at first unable to explain what might be happening. Ultimately, what they saw were similar results from study participants across the country who, like me, had begun treatment at extremely high viral load levels. At that point, they engaged in what I discovered was a rather unusual clinical trial protocol and “opened” the study, revealing to me that I was on Epzicom, and that they thought it was the Epzicom that was causing the viral load to spike. I was then given the options of staying the course, switching to Truvada or leaving the study altogether. I made the informed decision to switch to Truvada.

In large part because of the ACTG study findings, Epzicom today is no longer prescribed as part of a HAART regimen for those starting meds with an extremely high viral load, and my viral load has not once spiked to the higher levels where it had gone. And this is one of the salient reasons why research occurs, and why I am forever grateful to ACTG for the precision of their research and, when necessary, for the human touch and thoughtfulness they provide. Not once did ACTG clinicians tell me what to do; rather, they explained my options and the ramifications in the clearest of manners.

When asked by the ACTG communications manager the week before Christmas 2013 if I’d be available to speak about my study participation experiences, I did not hesitate for a moment. A few days later, a reporter from WGBH Radio contacted me as she was preparing a short piece about the ACTG/BWH funding. Later that day, she stopped by my house for an interview. She made me feel comfortable as we sat at my dining room table; she encouraged me to speak at length of my experiences with HIV and the research in which I’ve participated. It’s funny how much of an interview winds up on the cutting room floor—hear for yourself in the final radio story that aired in December 2013.

While the ACTG grants awarded last December are crucially important, there are complexities and challenges the Network and other research groups will face in the future. Dr. Kuritzkes told me that the main challenges faced by the ACTG in the near future include grappling with high complexity studies involving invasive procedures such as endoscopy, lymph node biopsy and leukapheresis for their “cure” agenda as well as establishing the infrastructure to conduct studies of multidrug-resistant (MDR) tuberculosis.

As I explained to the radio reporter, I do believe that in my lifetime there will be a cure for HIV, and the cure will be a result of the targeted research the ACTG and many others throughout the world continue to perform. How much closer are we to an HIV cure? As Dr. Kuritzkes explained to me, we are really just at the beginning in the search for a cure. Reports of the “Berlin Patient” provide us with some hope that the cure, or sustained remission of HIV, may be possible (in some patients).

As for an imminent cure, hopes on that front continue to remain elusive. Last December, the news was sobering from Boston about a potential cure for two patients involving bone-marrow transplants using cells not infected with HIV. “The main obstacle to cure is that HIV establishes a reservoir of long-lived latently infected cells—that is, the virus becomes silent in these cells but persists, essentially for the life of the patient,” explains Dr. Kuritzkes. “Because the virus is silent, the infected cells are not targeted for destruction by the immune system, nor are antiretroviral drugs effective in this setting. Developing drugs to activate HIV and immune strategies to rid the body of latently infected cells once they are active is a major focus of much cure research.”

While the research continues unabated, Dr. Kuritzkes is concerned about having adequate funding at ACTG clinical research sites so that his group is able to carry out their increasingly complex and technically challenging therapeutics research. “Rising personnel and regulatory costs in the face of stagnant or shrinking budgets has placed a significant strain on many of our sites,” he told me. “We hope that the budget deal recently negotiated by Congress will bring some stability to National Institutes of Health (NIH) funding and to the ACTG Network.”

I share his concern and I applaud the ACTG’s ability to maintain only the highest of patient standards, not to mention the quality of their data. As I age gracefully in the new HAILO study, I’ll continue to be with Dr. Kurtizkes and the ACTG team every step of the way.