The Chicago Tribune, Saturday, January 31, 1998
Sue Ellen Christian

In its first public acknowledgment that it must plan for the worst-case scenario, the International Association of Physicians in AIDS Care will announce Sunday that three pharmaceutical makers and a medical company have agreed to provide free drugs and testing to the first trial participants should the need arise.

The announcement is a nod to the criticism leveled at the group when it unveiled plans last fall to organize the first human guinea pigs to test a vaccine made with a live but weakened strain of HIV. Though the volunteers for the trial -- who now number more than 200 -- don't believe the vaccine will cause them harm, even a weakened strain of HIV might be capable of causing AIDS or other problems.

"We don't expect people to progress into AIDS, but we're trying to avoid that `reckless' label that some people have assigned us in the world," said Jose Zuniga, the association's deputy director and a trial volunteer.

In another new development, a plan to manufacture the vaccine is under review by the U.S. Food and Drug Administration. But the vaccine is still months, if not years, away from going into a human clinical trial. The FDA has approved no AIDS vaccines that include a live virus.

On Sunday, the physicians group will meet to plan its next steps to continue its push for a live vaccine, which it believes holds the best hope for protection against AIDS. The volunteers, a quarter of whom are physicians, argue that an epidemic as serious as AIDS demands measures beyond generally accepted science.

"Sixteen years into this epidemic and (new figures) say there are 16,000 new HIV infections a day globally," said Zuniga. "Can we afford not to explore every avenue of vaccine research and development as long as we are not being reckless and we are taking into account safety issues?"

Planning for the worst is just smart protocol, said Dr. John Phair, chief of infectious disease at Northwestern Memorial Hospital.

"That is their obligation, but it may also carry some weight with the FDA," said Phair. "It's unique in that they are planning for the failure of the vaccine. It's the only ethical thing to do."

Still, Phair and others, including Peggy Johnson, scientific director of the International AIDS Vaccine Initiative, say that it is too early to inject healthy humans with a live but weakened strain of HIV.

"It's laudable they are looking at the potential worst-case scenarios," said Johnson, "but it's not as important as first defining the safety of this vaccine."

Should participants in the human trial need therapy, the Chicago group has decided upon a four-drug approach that is the evolving standard of care, though not a cure for AIDS, say experts such as Dr. John Leonard, vice president of pharmaceutical development at Abbott Laboratories.

Abbott, Bristol-Myers Squibb and Hoffmann-La Roche have agreed to provide a lifetime supply of their respective antiviral drugs. One company, Glaxo Wellcome is still reviewing its donation, Zuniga said.

The vaccine trial would begin with five volunteers between the ages of 25 and 67 who are fully informed of the risks, Zuniga said.

Over a six- to nine-month period, those five would be monitored to see if they are developing AIDS. The objective in the first trial is to check the safety and tolerability of the vaccine, as well as how volunteers' immune systems react to it.

If the vaccine is determined to be safe, then six more individuals would join the trial. The number of participants would gradually escalate to top off at an as-yet-undetermined number.

"One of our commitments was to ensure that people volunteering for this trial and who are part of the trial are protected and we mitigate all medical and social harms involved in moving forward with this clinical trial," said Zuniga.

"Should someone require HIV-AIDS care and promising drug therapies and health-care services, they have that."

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