Details on Trials of Salk’s AIDS Therapy Emerge
New details emerged Thursday of the human trials at USC Medical School of a controversial AIDS immunization therapy developed by Dr. Jonas Salk, the polio vaccine pioneer.
Dr. Alexandra Levine, principal investigator for the study at USC’s Kenneth Norris Jr. Cancer Hospital, disclosed more information about participants in the study and the procedures being followed.
Levine said participants are infected with the AIDS virus and have swollen lymph nodes as well as laboratory evidence of deficient immune systems. Levine declined to specify how many patients are involved in the trial except to say it is between 10 and 15.
The patients are receiving one injection of whole AIDS virus particles that have been killed by exposure to radiation. The therapy is designed to strengthen the infected individual’s immune system and thereby prevent the development of AIDS.
Data Expected by June
“We expect to have enough scientific data available by June to be able to present our results (at the fourth annual International Conference on AIDS) in Stockholm,” Levine said in an interview. “If we are able to ascertain that the material is not toxic, we will immediately seek U.S. Food and Drug Administration approval to study it on a much larger scale.”
But Levine, a USC professor of medicine and executive associate dean, cautioned that there is no evidence to date that the therapy works.
Levine’s comments followed disclosure of the previously secret trials of Salk’s approach to AIDS therapy, which have been under way at the medical school for several months.
The study is one of the first to be authorized by the state Department of Health Services under a 1987 law that allows California researchers to test new AIDS therapies without seeking the approval of the FDA.
Levine said patients are being recruited from a waiting list of people who have expressed interest in participating in any of the AIDS experimental trials at County-USC Medical Center.
Salk’s theory is that the immunization treatments will reinforce the immune system, enabling it to keep the AIDS virus in check indefinitely.
Concern Over Approach
But some AIDS researchers fear his approach might backfire by overstimulating the immune system, causing it to wear out sooner. In addition, if the irradiation procedures to inactivate the AIDS virus turn out to be less than 100% effective, then a patient treated with Salk’s preparation might be injected with some live virus.
Patients are being warned of such potential toxicities in a written “informed consent” document, a standard procedure for safeguarding human research subjects. In addition, the document states that the “material has not been used in man before” and that “there may be side effects that are entirely unknown at this time,” Levine said.
