New Haven Pride Center

Rev. Alexander R. Garbera donates TCells for genetic modification.

The New Haven Gay & Lesbian Community Center’s first founding member, Rev. Alexander R. Garbera, was also the first to participate in a HIV/AIDS gene therapy clinical trial earning him the patient number 001. The gene therapy trial conducted by VIRxSYS, Inc. involved extracted Rev. Garbera CD4 Helper TCells, genetically modifying some of the healthy TCells to prevent HIV from infected them, then clone those genetically modified TCells and return them to the patient.

Rev. Garbera first received the infusion of 10 billion genetically modified cloned TCells in January of 2006. “At first I felt great,” reported Rev. Garbera as he went on to say “and was amazed that even months after my TCells climbed, and it wasn’t until about the 5 or 6 month the TCells began to drop again. Toward the end, I was dead tired and developing opportunistic infections.”

When asked why he didn’t take HIV/AIDS medications when his TCells were getting dangerously low, Rev. Garbera reported he was holding out for another reinfusion of genetically modified TCells after his one year anniversary, but as it turned out the protocol for reinfusion required less than 20% drop in TCell count. There was also some hope that the benefit of the modified TCells might show up later on in the 9th to 12th month after infusion.
On February 5th , VIRxSYS Corporation, a privately held company developing gene therapies for HIV and genetic diseases, presented the results from its Phase II trial of VRX496 at the 2008 Annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, MA.

“This appears to be a significant demonstration of slowing and possibly halting the replication of the infectious HIV virus in humans,” said Dr. Gary Blick, Medical Director, Circle Medical LLC. “VRX496 appears to cause wt-HIV particles to lose their envelopes and the in vivo pressure delivered by a patient’s own modified cells leads to massive quasispecie reductions and production of impaired and less replicative virions. This treatment shows tremendous promise.”

Obviously, results vary and when asked if he had any regrets about doing the study, Rev. Garbera said “Absolutely not. Although if the reinfusion protocol had exclusion criteria of less than 20% TCell Drop, I wish I would have known that last October and started taking meds. I know it’s all for science and we were hoping for a late rebound, but in retrospect, it was a dangerous game we were playing.”

This story is important for 2 major reasons. First, for those participating in clinical trials it is extremely important for them to know their options if things don’t go as they had hoped. Secondly, for those taking newly approved drugs, this story is a reminder that what may work of one person, may or may not work for another. This story itself should not discourage hopes about gene therapy, as it has had amazing benefits for others in the study.

Rev. Garbera feels that he still would have done it again and states that is important for people to be involved in clinical trials carefully accessing the risks and benefits. “We made tremendous progress in the treatment of HIV/AIDS,” said Rev. Garbera as he concluded: “These advances were not just made by pharmaceutical companies and researchers but the courageous, and sometimes desperate, warriors who risked their lives to find a better treatment and ways to eradicated HIV.”

Rev. Garbera is now eagerly waiting to get back on HIV/AIDS medications and hoping it will help him resolve the extreme fatigue and health problems that made a long cold Winter more miserable than it ought have been. Having been off HIV/AIDS meds for almost a year and half, Rev. Garbera feels that he should have a clean slate, and hopes that most medications will work again. The medications however, are not without their own side effects, and require almost perfect adherence to avoid creating HIV resistances.

Much needed HIV/AIDS research continues to find more tolerable medications with less damaging -- sometimes fatal --side effects, different approaches to manage and/or eradicate HIV, and develop vaccines and methods to prevent it’s transmission.

For more information about HIV/AIDS clinical trials in Connecticut, contact Circle Medical, LLC at (203) 852-9525, Or visit http://www.clinicaltrials.gov