CDC NATIONAL AIDS HOTLINE TRAINING BULLETIN #33 - March 5, 1993
National Institutes of Health.

The AIDS Clinical Trials Group (ACTG) of the National Institute of Allergy and Infectious Diseases (NIAID) has selected six additional candidate sites for the proposed trial of a novel, three-drug combination therapy for HIV infection. NIAID is accelerating the trial design process to open the trial as soon as possible, with a target date of this spring. The trial, ACTG 241, has been in development since early January 1993.

The following information, including design and locations for the trial, is subject to change until the trial protocol is finalized. In addition to expanding the list of sites, the number of planned participants has increased from 200 to 400. According to the proposed design, all participants must have advanced HIV disease. Selected participants must have taken antiretroviral drugs such as zidovudine (AZT) or didanosine (ddI) for more than six months. Patients will be randomly selected to participate in either of two therapy regimens: a combination of 600 milligrams (mg.) AZT and 400 mg. ddI daily versus the AZT/ddI combination plus a third drug, a non-nucleoside called nevirapine, in a 400 mg. dose daily, a total of 48 weeks. All three drugs inhibit the enzyme reverse transcriptase that HIV needs to replicate. Burroughs Wellcome makes AZT, Bristol-Myers Squibb Company makes ddI and Boehringer-Ingleheim makes nevirapine.

The following 16 sites, which are subject to change, are presently under consideration for the trial. An asterisk marks a newly added candidate site: University of Alabama at Birmingham; Albert Einstein College of Medicine, Bronx, N.Y.; University of California, San Diego; University of California, San Francisco*; University of Cincinnati, Ohio*; Cornell University, New York, N.Y.; University of Colorado, Denver; Harvard University, Boston; Indiana University, Indianapolis*; University of Miami, Fla.; University of Minnesota, Minneapolis; Mount Sinai, New York, N.Y*; University of North Carolina at Chapel Hill*; Northwestern University, Chicago, Ill.; University of Pennsylvania, Philadelphia*; University of Southern California, Los Angeles.

The design team selected the candidate sites from the 31 adult ACTG units, based on the unit's expressed interest as well as geographic area. Richard T. D'Aquila, M.D., is chairman of the trial and Martin S. Hirsch, M.D., serves as cochair. Both investigators are from Harvard University. ACTG 241 is one of many multiple-drug combination therapies for HIV that NIAID has in development or under way.

Individuals seeking additional information should call 1-800-TRIALS-A, which is open from 9 a.m. to 7 p.m. EST and available in English and Spanish.