Magazine article FDA Consumer

Progress Reports in the Battle against Acquired Immune Deficiency Syndrome

Magazine article FDA Consumer

Progress Reports in the Battle against Acquired Immune Deficiency Syndrome

Article excerpt

Progress Reports in the Battle Against Acquired Immune Deficiency Syndrome

Toll-Free AIDS Information

Information on privately funded clinical trials of drugs and biologies used to treat AIDS and AIDS-related illnesses is now available through a toll-free telephone service.

Since July, FDA has been providing information on privately funded trials to a special AIDS telephone line, the Public Health Service's AIDS Information Service. Information on NIH-sponsored AIDS and AIDS-related clinical trials has been available through the telephone line since May.

The toll-free telephone service is staffed by specially trained health information specialists, including some who speak Spanish. Service for the hearing impaired is also available. Information from the phone service is also accessible through DIRLINE, the National Library of Medicine's online computer data base. All inquiries are kept confidential.

By dialing 1-800-TRIALS-A, callers can find out: * where studies are located, and the eligibility criteria for participants, * the name of the product being studied and the purpose of the study, and * a contact and phone number for the company that is sponsoring the clinical trials.

FDA's participation in this telephone service is a response to a new law, the Omnibus Health Programs Extension Act of 1988, which requires that the Secretary of Health and Human Services establish a data base on AIDS-related clinical trials for public use. Before, such information was considered confidential and could not be publicly disclosed.

The new law requires sponsors to release information only about product effectiveness trials. However, FDA is encouraging them to list all trials involving AIDS or AIDS-related products, such as safety trials, and to release more information than is strictly required by the new law. For example, a company could provide the name, address, and telephone number of investigators conducting a particular study and more information about the trial, such as duration and need for hospitalization.

Zidovudine for Pregnant Women

FDA recently sanctioned the first trials of the AIDS drug zidovudine (also called AZT) in pregnant women infected with the AIDS virus, to see if it can protect newborns from the disease.

As part of the study, zidovudine, the only approved antiviral AIDS drug, will be given in the third trimester of pregnancy to 10 women who are infected with the human immunodeficiency virus (HIV), but who have no disease symptoms. Though not a cure for AIDS, zidovudine can prolong survival and improve the quality of life for those stricken.

Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, the sponsor of the tests, said the experiment is an effort to find a way of treating one of the fastest-growing categories of AIDS patients, newborn babies. …

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