1 Secretary of the U.S. Department of Health and Human Services (HHS) Louis W. Sullivan, M.D., announced that the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have developed a comprehensive plan for i . clinical evaluation and expanded availabil- l ity of ddl (dideoxyinosine). This promising ' antiviral agent that has shown activity against the AIDS virus in laboratory studies and in limited human studies although in lsome persons there have been potentially i serious side effects. ~ 5 “This plan offers some additional op- [tions for people with AIDS, and particu- larly for the thousands of AIDS patients who cannot tolerate therapy with AZT,” ‘Dr. Sullivan said. i- Dideoxyinosine, which was initially {developed by Samuel Broder, M.D. and tltobert Yarchoan, M.D. at the National ‘Cancer Institute (NCI), is one of a group of ;drugs including zidovudine, that inhibits lreplication of the AIDS virus. Phase I ‘mfety trials of ddl were recently completed .by NCI and AIDS Clinical Trials Group, ‘,(ACTG) of the National Institute of Allergy ‘and Infectious Diseases (NIAID), investi- gators at the University of Rochester and ‘New York University. Expanded Availability of ddl of toxicity also. In addition, an open safety protocal sponsored by the company will allow ddl to be studied in AIDS patients whose dis- ease has progressed substantially "despite zidovudine therapy. Although Bristol-Myers is not charg- ing for the cost of the drug in any of these programs, there are likely to be physician and laboratory charges associated with re- ceiving ddl through either Treatment IND or open safety protocols. Physicians, patients, and others inter- ested in the clinical trials can call 1-800- T'RIALS-A, a toll-free service offering information about AIDS clinical trials from 9 am to 7pm Eastern Time, Monday through Friday. Physicians interested in details of the Treatment IND and open safety protocol can call the Bristol-Myers toll-free number at 1-800-662-7999 daily from 8 am to 8 pm., Eastern Time. The company will immediately begin processing applica- tions from physicians for their patients for the Treatment IND and open safety proto- col. Bristol-Myers estimates that physi- cians with patients eligible for participa- tion in these protocols should begin to re- ceive the drug in about 2 weeks. 1 l These studies showed that, while ddl [appears promising, it has toxicities related to the dose taken; thus, its use requires tareful monitoring. ‘ Despite the promising early results with ddl, it is important to emphasize that _ izidovudine is the only drug with proven Joln ! lfficacy for the treatment of patients with ‘AIDS and advanced ARC. - - Under the Treatment IND, AIDS pa- Come to our Next Meetmg [ients who have experienced severe anemia trother dose-limiting adverse reactions to Mond7a_y3’ONoV 1 0 th zidovudine will be eligible to receive ddl - Pm lllrough a program administered and 30 Elmwood Ave» gfllnded by Bristol-Myers Company of New B” r“ “GT0 n York. The patients on this protocol will be (Ab0Ve VT CARES) monitored by their physicians for evidence 9 Insurance No Charge for Accepted Phone Consultation November 1989 Forconfidenfial AIDS Information Call y BARBARA Du BOIS PhD David M. Ross, ACSW Certified Clinical Social Worker Individual, Couples & Group Therapy Psychotherapy Bollan House ‘ PO. BOX 157 96 South Unionstreet (802) 862-3101 Bl'lStO|, 05443 Burlington, Vt. 05401 - & 105 Hill St., Barre, Vt. 05641 (802) 479-2115 A ' 7