Federal funding pullback chills HIV trials at UC San Diego

SAN DIEGO — The University of California, San Diego has paused at least five clinical trials designed to cure or control HIV after the National Institutes of Health issued guidance last week that new enrollments should be put on hold.

The nation’s foremost research funding agency told scientists “they should temporarily hold off on launching new studies that had not yet enrolled participants and that would not be complete by Nov. 30, 2027, when their current funding is set to expire,” according to The New York Times.

The NIH did not respond Friday to a request for a copy of the letter.

It is not the only delay involved in HIV research funding. The NIH has not yet renewed funding for four clinical trial networks that have long connected patients to investigational new drugs. Experts fear that if funding is not continued, a vital resource would be at risk because the networks have been used to test drugs and other treatments for many conditions — not just HIV.

UC San Diego participates in two of these networks.

The world’s largest and longest-running is ACTG, Advancing Clinical Therapeutics Globally, a consortium of 59 HIV clinical trial sites on four continents that pursues research on HIV and other co-occurring diseases such as tuberculosis and hepatitis B. UCSD is among ACTG’s 14 original members, which were designated as AIDS treatment evaluation units by the NIH in 1986.

Network members have conducted more than 3,000 trials, including azidothymidine, often called AZT, the first antiretroviral drug, which the U.S. Food and Drug Administration approved in 1987.

It was the first treatment for acquired immunodeficiency syndrome, and UCSD’s Dr. Douglas Richman co-chaired AZT’s first studies, making UCSD one of a dozen trial sites and enrolling 32 San Diego residents living with HIV.

Over the ensuing four decades, generations of scientists have built on that early work, always pushing for a vaccine that could prevent infection but also inventing antiretroviral therapies such as Truvada and Descovy, which, if taken regularly, can both reduce the risk of infection by up to 99% and also drive HIV levels so low that the virus is no longer transmissible.

While the long-running search for an HIV vaccine still has not borne fruit, science has found endless avenues of investigation to help people live better lives if they do become infected.

UCSD’s clinical trials office lists 37 current HIV trials, a dozen of which are currently enrolling participants.

Fifteen ongoing trials, and six of those now enrolling, use the ACTG clinical trials network, UCSD confirmed Friday. The remainder are trials run by drug companies and are not directly affected by the current NIH dust-up.

It is unclear how federal funding will flow to trial networks such as ACTG going forward. While an NIH spokesman told The New York Times that it intends to continue investing in HIV research, the paper notes that major cuts to federal HIV research staffing have already occurred, a $258 million program researching an HIV vaccine was cut last year, and funding renewal, which occurs every seven years, was not announced in late August as originally indicated.

Dr. Tim Wilkin, head of the UC San Diego Division of Infectious Diseases and Global Public Health, said that the issue is not just about the funding of current trials. The biggest near-term decision has been not to start five trials that were expected to get underway soon.

“We have probably five in the next six months that we’re planning to start,” Wilkin said. “We won’t be able to (move forward) because of the uncertainties in funding.”

Some of these trials, he said, are aimed at finding an HIV cure or being able to control the disease without medications, and one would further investigate the use of long-acting antiretroviral drugs that now require shots just twice per year, rather than daily dosing, and may be extended even longer.

These, he noted, are not whimsical ideas that researchers dreamed up in an afternoon.

“People have worked very hard and gone through a rigorous review process to get these trials up and running,” Wilkin said. “We only really perform studies that are of the highest priority, and to slow that process down puts us, you know, years behind where we would have been otherwise.”

UCSD researchers also conduct trials through IMPAACT, the International Maternal Pediatric Adolescent AIDS Clinical Trials network. Formed in 2006, IMPAACT lists 49 sites worldwide.

Dr. Stephen Spector, who directs the UCSD Mother-Child-Adolescent HIV Program, said that the network has been crucial to developing ways to reduce the transmission of HIV from mother to child.

There is more work to do in using long-acting antiretroviral drugs to help new mothers better care for their babies.

“You could give a mother a long-acting drug or an infant a long-acting drug they can breastfeed, and so mothers would not have to take a daily medication to suppress the virus,” Spector said. “Those are just the kinds of studies that we’re just preparing to start.”

The researcher estimated that UCSD receives several million dollars in funding from HIV networks to conduct multisite trials and the work involves 40 to 50 employees.

While the NIH has not outright said that it intends to stop funding bedrock HIV networks, many fear this will be the case. And they make the point that doing so would mean abandoning critical and highly flexible infrastructure that has taken decades to build.

Experts cite COVID-19 vaccines as a prime example of the power available in HIV trial networks. In 2020, faced with a need to test candidate vaccines in thousands of patients as quickly as possible, the NIH combined four different HIV networks into what it called the COVID-19 Prevention Trials Network, a resource that a 2023 study found served more than 130,000 vaccine trial participants.

“It really was about having the doctors and nurses and laboratory technicians that were experienced in doing clinical trials and also handling specimens in a biosafe manner,” Spector said. “These were people who were used to handling specimens of HIV and were comfortable handling specimens of COVID.

“And this includes the people who are on the front lines who are drawing the blood.”

ACTG played a central role in investigating a drug to treat mpox, previously called monkeypox, when the disease spread worldwide in 2023. The network was effective, Wilkin explains, not just for its ability to handle lab samples appropriately.

“We also have regulatory experts that can make sure that we’re in compliance with all of the various FDA and European regulations,” Wilkin said. “When you’re conducting clinical trials of new agents that really have the highest scrutiny, you really need staff that has done that type of work and really know how to conduct that research in a high-quality, compliant manner, and that can’t be built overnight.”

For some, the current attack on HIV research feels exceptionally personal.

Michael Donovan, managing director of POZabilities San Diego, a nonprofit support group of HIV-positive men, said his life was literally saved by the antiretroviral breakthroughs that ACTG and other HIV trial networks have delivered.

The experience left him a lifelong follower of HIV science, which, on Friday included attending an all-day research symposium at UCSD titled “Beyond Survival: Redefining Longevity in the Era of HIV.”

Having watched the process of scientific vetting that decides which trials ultimately get funding and which don’t, he said it is particularly galling to see political overtones develop.

“At the end of the day, if you’re a person of color, if you’re gay, if you have a disease that’s associated with something like HIV or drug abuse or whatever the case may be, yeah, you’re being shoved down the priority list to the point where we just die off and go away,” Donovan said. “But we don’t do that well; we get noisy.”

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