United Press International; Monday, September 22, 1997 7:48 PM EDT
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says the group of physicians and other volunteers would be sidestepping crucial tests if they inject themselves as they announced late last week. The group says they they will do it whether or not they receive approval for the trial from the Food and Drug Administration.
More than 2,100 healthy volunteers have participated in clinical HIV vaccine trials. But none of those involved a live strain of the virus.
Fauci told United Press International today, "I can't imagine the FDA will approve it or will approve it rapidly."
The monkey equivalent of the virus has protected the animals from AIDS, but not without causing other safety problems. Plus, unlike other live virus vaccines, such as polio, HIV can insert its genetic code into human cells, and "could stay with a person forever." Or, he said, the weakened form of the virus that would be injected might revert to a more virulent form.
"Although the concept is quite reasonable," Fauci said, "when you are dealing with HIV virus there are a number of problems of safety."
At NIH, Fauci said researchers do plan to vigorously pursue research into an HIV vaccine that uses a live virus for use in high risk groups of people who are uninfected. Such groups, for example, would includes people in a relationship with an HIV-infected partner, and in countries with high percentages of HIV infection as in some African countries.
Fauci said he and other NIH researchers do plan to meet with members of the group, International Association of Physicians in AIDS Care to discuss the issues, but he said no policy decisions would be made during the meeting.
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