FDA Approves AIDS Drug for Tests, Group Says

A San Francisco group that organized underground tests of an AIDS drug derived from Chinese cucumber roots won government approval to resume testing with a purified form of the drug, an official of the group said Thursday.

Project Inform, an AIDS treatment and education group, planned to announce Friday that the U.S. Food and Drug Administration has approved its application to conduct tests of the drug, known as Compound Q, on about 100 patients, said Terry Beswick, research director of the group.

An FDA official who spoke on the condition of anonymity confirmed the approval and said it brings Project Inform under the agency’s sanctioned clinical trials system, assuring that the group’s plan conforms to government standards for testing.

Working with Project Inform to come up with a study design that meets FDA requirements was a better alternative than trying to put the group out of business, the official said.

In the secret tests, about 60 patients were given infusions of Compound Q by doctors in San Francisco, New York, Miami and Los Angeles, according to Project Inform officials. Two patients died during the trial and three others suffered severe dementia or seizures, but recovered.

The purified form of the drug was developed at UC San Francisco and Genelabs of Redwood City. This version of the drug is being studied on patients in FDA-approved tests at San Francisco General Hospital.