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Clinical trial will test controlled 'drug holidays' to counter HIV

Researchers have received approval for a new clinical trial to test carefully controlled interruptions in HIV patients' drug regimens as an approach to boosting their immune systems, eventually to the point where they can manage their infections without the need for drugs. Patient recruitment will begin immediately for the trial, which was conceived by a team of scientists headed by Luis J. Montaner, D.V.M., D.Phil., an assistant professor at The Wistar Institute, and will be overseen by clinicians in the University of Pennsylvania Health System.

Current state-of-the-art therapy for HIV infection is to administer a cocktail of three drugs that suppresses the virus, often to undetectable levels. While the treatment, known as Highly Active Anti-Retroviral Therapy, or HAART, is very effective, it is too expensive to represent a worldwide solution to the problem of HIV and AIDS. It is also complex and burdensome for patients to adhere to, and it is often accompanied by disturbing, potentially dangerous side effects. While patients are under therapy, however, the number of viruses in their blood drops, and the immune system recovers its ability to respond.

Researchers at The Wistar Institute and elsewhere believe that carefully structured "holidays" from the drugs - known as intermittent HAART - might lead, in effect, to autovaccination against HIV. Patients' ability to mount a response to their own virus has been observed by Dr. Montaner and his colleagues in a subset of chronically infected patients who had maintained long-term viral suppression with their medications before a controlled interruption of treatment. The present trial will test the capacity of these responses to control HIV without medication.

"Many people feel that the answer to AIDS will be found in improved antiviral drugs," says Dr. Montaner, principal investigator on the scientific study that led to development of the new trial. "Immunologists like myself, however, see in the drugs an
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Contact: Franklin Hoke
hoke@wistar.upenn.edu
215-898-3716
The Wistar Institute
15-May-2000


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