HIV Patients to Be Used in UCSD Test of New Drug That Spurs Immune System
Using HIV-infected patients, UC San Diego doctors will launch a small study next month of a vaccine-like drug that they hope will treat the virus, physicians announced Thursday.
In the six-month study, the antibody-based drug, called 3C9, will be tested on 24 HIV-positive patients to see if it is safe. Such trials on infected individuals have already occurred with similar drugs, such as Jonas Salk’s experimental AIDS vaccine.
The drug 3C9 is intended to stimulate the body’s immune system to produce antibodies that will attack and neutralize the human immunodeficiency virus (HIV), which causes AIDS.
“There’s good theoretical basis for it to work, but we also have a lot of respect for this pathogen’s ability to evade our best efforts,” said Dr. J. Allen McCutchan, a UCSD professor of medicine and director of the California Collaborative Treatment Group, a state-funded, multi-center research organization directed from UCSD.
This type of trial is the first hurdle in a long series. At the end of six months, if the patients have shown no ill effects from receiving the injections once every four weeks, researchers will begin another, larger trial. The second study would seek to determine whether the drug helps halt the virus.
During the first trial, which will start in February, doctors will closely monitor patients for any harmful side effects from the drug. They will also measure the patients’ immune response.
If the drug is eventually found to be both safe and effective, it will be used to prevent the spread of HIV among uninfected people as well as to treat those who are infected, said McCutchan, director of the study. A treatment for the AIDS-causing virus, since it was discovered a decade ago, has eluded scientists.
“It’s just too early to tell. This is a good idea and something that needs to be tried,” McCutchan said.
The drug acts by focusing the immune system on a particular target, the site where the virus binds to the body’s disease-fighting CD-4 white blood cells. Doctors believe this is a key target because it is present in all strains of the virus.
“It is our hope that this will help overcome problems associated with rapid mutation of the virus,” said William H. Rastetter, president of IDEC Pharmaceuticals Corp., which developed the drug in its offices in Mountain View and La Jolla.
Researchers hope 3C9 will prompt the body to produce large amounts of HIV-neutralizing antibodies by stimulating the patient’s own immune response. IDEC officials said at a news conference that they are unaware of any other vaccine under development that could kick off these neutralizing antibodies, as 3C9 has in a laboratory setting.
Doctors are recruiting patients in the San Diego area to participate in the trial, which is open only to people with a CD-4 cell count of more than 600. Uninfected individuals usually have a CD-4 cell count of 800 to 1,000.
