COVINGTON, Ky. — One of the things that kept Carl Fox going after he contracted HIV in 1985 was a promise that he made to himself.
Fox vowed to survive, he said, so he could testify to what people with HIV and AIDS encountered back then.
“When they try and rewrite history and say how they just stepped right up when AIDS first popped on the scene. Well, they just right out of the box were saving our lives and taking care of everybody,” Fox said. “I’m going to be the old, bent-over queen in the background that’s going to say, ‘Excuse me. I was there. And while we did get to the finish line together, I can tell you about the early days, and it wasn’t so good.’”
In fact, he said, it was heartbreaking.
Fox lost more than 200 friends to AIDS during those early years of the crisis, sometimes attending several funerals a week. He waited years before there was medicine for HIV he could take without feeling unbearably sick. It was hard to believe there could ever be an end to the suffering.
But now the finish line has never looked closer.
This month marks the halfway point of Fox’s participation in a federally funded TRAILBLAZER study that’s altering the white blood cells of patients to try to control the devastation of HIV without daily medication. He is allowing WCPO to chronicle the experience.
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In January 2020, Fox sat for four and a half hours while blood passed from a large needle in one arm through a machine that removed the parts of his white blood cells needed for the study. What was left got pumped back into the other arm.
Then last December, he and his fiancé, Terry Bond, arrived at Cincinnati Children’s Hospital Medical Center research center before sunrise for a 10-hour infusion of chemotherapy drugs that are part of the study. A few days later, Fox had a four-and-a-half-hour follow-up appointment to have his white blood cells reinfused.
Because he’s taking part in a double-blind study, Fox doesn’t know if his cells were altered as part of the research or if they were pumped back into his body unchanged.
During an appointment this month, Fox had his white blood cells drawn. If they were altered as part of the study, researchers want to see if they are still circulating in his bloodstream and, if so, in what amount, said Dr. Carl Fichtenbaum. The tests also measured the amount of HIV in Fox’s body, Fichtenbaum said, and whether that has changed.
“It’s a long process,” Fox said. “I was very eager to get this started, and now it’s a whole lot of hurry up and wait.”
Broader implications
That’s all part of the deal with this kind of research, said Fichtenbaum, a professor in the Division of Infectious Diseases in the Department of Internal Medicine at the University of Cincinnati College of Medicine. He’s also a principal investigator on the TRAILBLAZER study and has been Fox’s doctor for years.
“The research process takes time if you really want to generate the right information,” Fichtenbaum said. “You have to design the study and collect information the right way. You can’t really cut any corners. That would be unwise. And as much as people really feel like they know what they got and how it’s affecting them, this is why we do blinded studies, because we know that the human mind is very powerful.”
It’s far too early to say whether the altered blood cells will result in what Fichtenbaum calls “a functional cure,” which would protect people from the ravages of HIV and AIDS without having to take daily medications that can have serious side effects.
The last of the 30 patients in the TRAILBLAZER study finally have been enrolled, Fichtenbaum said. The study is a collaboration between researchers at UC, Case Western Reserve University in Cleveland and the University of California-San Francisco. Only about two-thirds of the patients will have the genes in their blood cells modified. The others will serve as a control group and will have their unchanged cells reinfused into their bodies.
“The final participant will receive their blinded study product in January,” Fichtenbaum said. “Whether that’s modified or not, we don’t know. And then we will finish follow-up for this study in January of 2024.”
The good news, he said, is that so far none of the patients in the study have had any “significant adverse side effects.”
“Some people have had some annoyances and things weren’t always perfect for them,” he said. “But everybody’s generally been pretty healthy, and that is really reassuring that it’s not harming anybody.”
Researchers won’t know until early 2024 whether the altered cells are working – or how they work, he said. But no matter what, he said, the results will provide valuable insights.
“As we move forward in the future, understanding whether it is safe to modify genes and then put things back into human beings and see whether this can be done on any scalable level is a really important question,” Fichtenbaum said. “Because if what we can do is figure out that we render HIV less harmful to people or we can decrease the amount of HIV in people, that would be a big advance and would tell us that doing some kind of gene-editing and providing people with products that can modify the natural history of a health care problem would be a big advance.”
Learning that it doesn’t work would be an important advance, too, he said, as would learning that the procedure was harmful in some way.
“We don’t want to hurt people,” Fichtenbaum said. “So almost any outcome that you can have from this kind of study I think is very important and will be informative to other research that comes in the future.”
‘They are truly the heroes’
Fox was hopeful that some side effects he experienced after receiving the chemotherapy medication meant he received the altered cells.
But he said he knows he must be patient and trust the process.
“I’m glad it’s not been worse,” said Bond, Fox’s fiancé. “There’s a lot of drug studies that can have all kinds of side effects and bad things and ups and downs. And this has actually been fairly smooth, all things considered.”
Fox agreed.
“The scariest part about starting one of these procedures is what is going to happen, and your mind can go in all different areas with that,” he said. “As Terry said, so far I’ve been very blessed. And part of that blessing has been the staff at all the facilities have treated me with just an unimaginable amount of compassion and care.”
Above all, Fox said, he trusts Fichtenbaum and has faith that he has Fox’s best interests at heart.
“Confidence from Dr. Fichtenbaum is what he projects constantly,” Fox said. “Compassion and empathy for the position I’m in.”
Fichtenbaum said he’s grateful to Fox and all the study participants.
“This is truly an amazing commitment that allows us to hopefully advance the science and understand more about how HIV affects people,” Fichtenbaum said. “They are truly the heroes in my book of research and the ones who will make a difference and blaze a trail for others in the future.”
Fox said Fichtenbaum and his team have thanked him repeatedly, and he sometimes doesn’t know how to feel about that. Then he thinks about all the friends he has lost.
“The one thing that I hope does happen,” Fox said, “about being thanked for our contribution, is the contribution of all those who died – who didn’t make it. Because they were beautiful people. They were just beautiful people.”
Fox tries not to dwell on that too much, he said, because it makes him so sad.
But it’s been hard not to think back to those early days of the AIDS crisis, he said, because the COVID-19 pandemic feels so similar in many ways.
“That, I have to say, has been probably one of the toughest things about COVID and this treatment that I’m going through,” Fox said. “The commonalities of it all, the similarities of watching so many people die.”
The big difference, though, is that there are treatments available for COVID-19 and vaccines that can help save lives, he said, options that people with HIV and AIDS didn’t have in the 1980s and early 1990s.
Fox said he’s grateful to have survived long enough to see how far the science has come.
“I know that in the end, they will cure this,” he said. “And I’m hopeful that I’m going to be part of that process. One, to get rid of this lousy disease. But, two, because of the whole idea that I, you know, I survived, and I lived. And I got to the end and made it through it.”
For himself, of course, and for all the beautiful people who didn’t.
WCPO 9 will be chronicling Fox’s experience during his participation in the TRAILBLAZER study. This is the third installment. The first is available here. The second is available here.
More information about the study is available online.
Lucy May writes about the people, places and issues that define our region – to celebrate what makes the Tri-State great and shine a spotlight on issues we need to address. To reach Lucy, email lucy.may@wcpo.com. Follow her on Twitter @LucyMayCincy.
