Isle healthcare officials and HIV/AIDS advocates say a decision by a federal agency to discontinue funding of the Hawai'i AIDS Clinical Trials Unit will have "devastating" consequences for hundreds of patients and the doctors who treat them.

The unit is the only research program in the state dedicated exclusively to HIV/AIDS.

Since it was established 15 years ago at the University of Hawai'i's John A. Burns School of Medicine, it has participated in 275 drug studies involving a total of 1,000 patients. It is part of a network of 48 national and international sites funded by the National Institute of Allergy and Infectious Diseases.

During that time, the Hawai'i AIDS Clinical Trials Unit has used its expertise to become an invaluable resource for the medical community and a frontline healthcare provider to HIV/AIDS patients across the state, advocates said.

Paul Smith, 42, of Waikiki, said his participation in one of the unit's clinical trials enabled him to walk again after experiencing severe pain and numbness in his extremities. Smith, who has AIDS, is a patient at the Clint Spencer Clinic at Le'ahi Hospital.

"They helped me make it to a point where I can sort of function semi-normally," he said. "They're quiet and they're in the background, but they're doing things that are so important. To hear that they are probably going to close down is very devastating."

Program director Dr. Cecilia Shikuma said she was notified by telephone last week that the Hawai'i AIDS Clinical Trials Unit was among several sites that would be losing federal support, effective at the end of the year, and to no longer enroll patients in pharmaceutical trials.

In a statement to The Advertiser, the NIAID said that "at this time, only a small number of HIV/AIDS network clinical site funding decisions have been finalized" and that the agency will not comment on the awards until the process is done. The agency is part of the National Institutes of Health.

In addition to clinical trials, the unit two years ago established the Spencer Clinic that today treats 300 to 350 patients. Shikuma and her staff members also regularly travel to Hilo and Kona to see patients who might not otherwise be able to find or afford doctors.

The program's obstetrician-gynecologist either cares for or consults on the vast majority of HIV-positive pregnant women in Hawai'i, providing care in preventing HIV transmission to their babies, Shikuma said.

"We view ourselves as the community experts, and we feel that we should give back to the community," she said. "There are not many people who know how to treat HIV."

Already there is concern about an exodus of doctors who treat HIV/AIDS patients, especially on the Neighbor Islands.

As these physicians retire or leave the state, other physicians are dropping or not accepting HIV/AIDS patients because of the complex care they require and low insurance reimbursement rates, said Peter Whiticar, who heads the state Department of Health's STD/AIDS Prevention Branch.

Whiticar and others said physicians and AIDS service organizations have come to rely on the Hawai'i AIDS Clinical Trials Unit to "pick up the slack" from an overextended system. He said he doesn't see any other agency stepping in to fill the void once the unit is shut down.

"This is one of our major professional HIV resource centers, providing specialized support especially for the Neighbor Islands and small-practice doctors with HIV patients in their practice," he said. "It's really devastating. In a large state with many big universities and hospitals and large faculties, it would be much less of a big deal than in a small state like this."

Spencer Clinic operations and many of the other patient and physician services provided by the Hawai'i AIDS Clinical Trials Unit are not directly related to the $1.5 million annual grant the site receives from the National Institute of Allergy and Infectious Diseases for clinical trial duties.

But the grant makes up two-thirds of the unit's funding and the program cannot continue without the money, Shikuma said.

Michael Burnett, who serves on the unit's community advisory board, said the NIAID decision to no longer fund the Hawai'i site also means patients here will be denied access to potentially life-saving medications available elsewhere in the country.

"It's really scary for a lot of people that there would not be the equitable access to care if these clinical trials cease to exist," he said. "For so many people, that is absolutely a lifesaver, truly."

Burnett, former executive director of Gregory House, a housing program for people with HIV/AIDS, was diagnosed with HIV in 1989 and has participated in several drug studies.

"For me, it's been a point of hope, and there's not a great deal of hope right now. There are medications available that will prolong life, but they have incredibly adverse side effects and they are not a cure. So to have clinical trials that you can, from time to time, participate in, it's a very hopeful thing."

Shikuma has contacted state and federal elected officials to enlist their support in persuading the NIAID to reverse its decision. She suspects the local unit is an apparent victim of "a numbers game" because of the state's relatively low population of AIDS patients.

At the end of 2005, there were 1,305 known AIDS cases in the Islands and at least 1,542 deaths from AIDS-related causes since 1983. There is no reporting system for HIV cases.

Shikuma said an NIAID official told her that although the Hawai'i site was more highly rated than some of the units that will continue to receive grants, there were "other extenuating circumstances," such as scientific needs, geographic distribution of sites and whether sites had access to special populations.

But those are some of the very reasons the Hawai'i unit should remain open, Shikuma said.

"Hawai'i has a unique ethnic makeup, and in our 15 years of existence our site has provided 34 percent of the entire number of HIV patients of Asian and Pacific Islander descent enrolled in national antiretroviral trials — our little unit," Shikuma said. "To me it's irrelevant that the rate of HIV infection is relatively small in the Asian community. I think it deserves to be represented in clinical trials."

And Hawai'i's geographic isolation means patients cannot easily participate in clinical studies offered at other units in the network, she said.

Most antiviral drugs to treat HIV/AIDS, such as AZT, were initially available only through clinical trials, and the Hawai'i unit has been responsible for bringing new medicines to the state, Shikuma said. "All of us know patients who the only reason they're alive today is by participating in these trials," she said.

The Hawai'i unit also has made important contributions to the AIDS clinical trials network, including devising protocols for at least 10 drug studies, Shikuma said. In addition, the local site is a partner in federal HIV/AIDS research and training programs in Thailand and Vietnam, where the disease is spreading at an alarming rate.

Back home, the unit's absence will be deeply felt by the medical community, according to Whiticar. He said Shikuma and her staff advise the Health Department on AIDS/HIV programs and policies, and that physicians in the community regularly call on them for help.

Burnett said his own doctor has sought advice from the unit.

"When I've had problems and my primary physician is scratching his head, those guys have always been right there to help consult and figure out the problem," he said.

The closing also likely will affect the unit's 25 staff members, who include physician researchers, clinical trial nurses, research pharmacists and a data manager. In most cases, their salaries are paid in part by the NIAID grant, but they also work on other projects with different funding sources.

Shikuma said it's not yet clear what will happen to the staff when funding for the clinical trials unit ends.

Reach Christie Wilson at cwilson@honoluluadvertiser.com.