Searchlightwinter ’98/’99
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SEARCHLIGHTWinter ’98/’99 QUARTERLY NEWS FROM AIDS RESEARCH ALLIANCE The National Leader in Fast-Track AIDS Research AIDS RESEARCH A L L I A N C E Board of Directors Kenneth C. “Cam” Davis Financial Advisor Sanford C. Bernstein & Co. Chair H. Smith Richardson, III Vice-Chair What’s News— Chuck Williams Chuck Williams & Associates Treasurer * * * * * * Tim Engel Senior V. P. of Production Clinical Research People & Developments Walt Disney Feature Animation Secretary Daniel Bowers, M.D. Pacific Oaks Medical Group VaxGen, Inc. has selected AIDS RES E A R C H AIDS RESEARCH Alliance received national press Nancy Bresler Alliance to participate in the world's first large-scale coverage of our first inoculation of a volunteer in Sandy Bresler Talent Agent study of a preventative AIDS vaccine, AIDSVAX™. VaxGen, Inc.’s preventative AIDS vaccine study. Bresler, Kelly & Associates Bruce Cochran, Atty. A total of 5,000 HIV-negative people at risk for sex- Television, radio, and newspaper reporters wit- Tim Corrigan ually-transmitted HIV infection will be enrolled at nessed and photographed the injection, which was Executive V.P. Bates Worldwide approximately 40 sites throughout North America followed by a large press conference. Steve Martin, Friley Davidson Entrepreneur in this 3 year, double-blind, placebo controlled mayor of West Hollywood, and West Hollywood city David Hart, M.D. st u d y . councilman Sal Guarriello were also on hand to Wilbert Jordan, M.D. Director, Oasis Clinic (Coverage Begins on Page 4) lend their support. & AIDS Programs King/Drew Medical Center * * * Arnold Kassoy * * * Partner The Holiday Card Campaign is now underway for Manatt, Phelps & Phillips Virco, N.V. has selected AIDS RESEARCH Alliance Matt Redman to participate in a study that will determine the 8th consecutive year. We are offering 4 new McCown-Redman Design and inspiring selections—"Guardian Angel" (a Robert Winters, M.D. whether anti-HIV drug choices made with prior Chief Executive Officer knowledge of the drug resistance properties of drawing by Amy Dakos), "Still Window" (a collage Gregory S. Britt by Louella Hill), "Candle" (a photo by A r m o n d Director of Clinical Research patients' virus can improve the patients' responses Stephen J. Brown, M.D. Ba g d a s a r i a n ), and "Unknown Angel" (a photo by Medical Director to their medications. We are currently enrolling George C. Fareed, M.D. this open-label, randomized trial that will take Jayme Thornton)—in addition to a popular design Medical and Scientific Advisory Committee place in 20 centers nationwide. that we have retained from last year ("City Star"). Harvey Abrams, M.D. Bisher Akil, M.D. (Article on Page 13) H. Aaron Aronow, M.D. (Article on Page 3) Victor Beer, M.D. Aron Bick, M.D. * * * Joseph Church, M.D. * * * Gary Cohan, M.D. AIDS RESEARCH Alliance's Institutional Review Richard Cooper, M.D. Four AIDS RESEARCH Alliance staff members con- George Fareed, M.D. Erik Fleishman, D.O. verged upon the 12th World AIDS Conference in Board (a.k.a. IRB), which ensures the highest stan- Parkash Gill, M.D. Jonathan Goldsmith, M.D. dards of ethical treatment of study participants, has Michael Gottlieb, M.D. Geneva, Switzerland this summer to uncover areas Edward Grant, M.D. expanded its membership and undergone a David Hardy, M.D. of HIV/AIDS science now ripe for clinical investi- Scott Hitt, M.D. change in leadership. Three new members have John James gation. In this issue, we provide extensive coverage A. Kay Kalousek, D.O. Mark Katz, M.D. of major advances in our understanding of been elected to serve on the IRB, and S t e p h e n Peter Kraus, M.D. James Lee, D.O. Fefferman, M.F.C.C. was voted in as chairman. Albert Lerner, M.D. HIV/AIDS as presented at the conference. Aliza Lifshitz, M.D. We extend our gratitude to his predecessor, Fa t h e r Thomas Lockner, M.D. * * * Thomas Magee, M.D. Douglas Glassman, for 5 years of dedicated service Steven Miles, M.D. Michael Moret, M.D. Frequently, clinical trial results for anti-HIV drugs Phillip A. Musikanth, M.D. as a member, and later chairman, of the IRB. Gregg Olsen, M.D. fail to reflect the probable outcome for the average Amit Patel, M.D. (Article on Page 11) Henry Poscher, Ph.D. patient that uses these drugs after they receive FDA Eugene Rogolsky, M.D. Peter Ruane, M.D. approval. This has implications for how communi- * * * Jesse Sanders, M.D. Karen Sandler, D.O. E Anthony Scarsella, M.D. ty members should interpret clinical trial results Circle of Hope, AIDS R SEARCH Alliance's major Michael Scolaro, M.D. Elyse Singer, M.D. and potentially for how future studies should be donor campaign, kicked off with a bang in '98, Brian Smith, D.C. Brian Terry, M.D. designed and analyzed. The article, " C l i n i c a l adding 27 new members to the program. We are James Thommes, M.D. Daniel White, M.D. Trials to Clinical Reality", on page 23 discusses grateful to all those who have contributed to our Herbert Wiesinger, M.D. Kevin W. Williams, M.D. these issues in depth. mission of finding a cure for AIDS. Ronald Wing, M.D. Founders In Memorium * * * * * * Paul Rothman, D.O. Matthew Rushton 2 SEA RC H L IG H T quarterly news from AIDS RESEARCH Alliance AIDS falls out of the top 10 list of killers— A National Leader in Fast-Track AIDS Research Our own “top 10” list of reasons why ARA envisions a future in which HIV and its effects we are not celebrating are eliminated from infected individuals, and a vac- cine preventing new cases eradicates the virus. ARA’s mission is to find and accelerate the devel- 1) No one has been cured. opment of effective treatments for HIV and its compli- 2) 2.3 millions deaths worldwide were due to AIDS in 1997. cations. We do this by conducting cutting edge 3) 5.8 million people were newly infected worldwide in 1997; 40,000 were in the research and clinical trials in order to improve the longevity and quality of life for all people with U.S. alone, with infection rates significantly increased in people of color com- immune deficiency. munities and in women. 4) The reduction in deaths in the U.S. in ‘97 are as a result of the initial benefits EXECUTIVE EDITOR Gregory S. Britt gained from multi-drug cocktail therapy heralded by the FDA-approval of pro- EDITOR tease inhibitors 2 years previously. These numbers reflect death rates before the Andrew Korotzer, Ph.D. first wave of viral resistance began to emerge. MEDICAL EDITORS 5) Viral resistance to currently available drugs occurs in as much as 50% of all George C. Fareed, M.D. Stephen J. Brown, M.D. infected people under treatment in the U.S. EDITORIAL CONSULTANT 6) Cross-resistance between drugs of the same class means that treatment options Michael Slattery for individuals with drug-resistant virus are limited at best. Emerging new CONTRIBUTORS TO THIS ISSUE antiretroviral drugs are all “me-too” drugs from already-established drug class- Andrew Korotzer, Ph.D. es—meaning that if you are resistant to a currently-approved protease Gregory S. Britt Stephen J. Brown, M.D. inhibitor, you will likely be partially or totally resistant to the new protease Karen J. Wellenkamp inhibitors under development. PRODUCTION COORDINATOR 7) Cocktail drug therapy does not restore the ability of the immune system to recog- Karen J. Wellenkamp nize and help fight HIV—leaving individuals totally dependent upon anti- SUBSCRIPTION COORDINATOR Carlo Danielson HIV drugs to continually suppress viral replication. Despite many individuals reaching “undetectable” viral levels in the blood, replicating virus is still found ART DIRECTOR Chris Davies in significant amounts in other sites in the body such as resting memory cells, ART PRODUCTION the lymphatic tissue and the brain. Mad Macs Communications 8) Side effects and drug toxicities to current anti-HIV drugs are piling up—reduc- DIGITAL PRE-PRESS STUDIO ing quality of life and making the compounds intolerable for an increasing Fontographics number of individuals. AIDS RESEARCH ALLIANCE MEDICAL EXECUTIVE COMMITTEE 9) Multi-drug cocktails are not available to most people with HIV disease in the Robert Winters, M.D., Chair world—leading to a dramatically rising AIDS death rate worldwide. Peter Anton, M.D. Daniel Bowers, M.D. 10) Unless new drugs are identified and developed to help combat emerging resis- James Corti, R.N. tance and inhibit novel viral targets, AIDS death rates in the U.S. will likely George C. Fareed, M.D. accelerate once again to previously high levels as current treatments fail due to David Hart, M.D. Wilbert Jordan, M.D. resistance or drug-class cross-resistance. Ian McGowan, MB, D. Phil, MRCP Michael K. Wensley, M.D. Sorry for the reality check. Se a r c h l i g h t is published quarterly for the HIV community by AIDS RESEARCH Alliance, a California nonprofit corpora- tion which is solely responsible for its content. Noncommercial reproduction is encouraged provided the appropriate credit is given. Circulation: 16,000. Copyright© 1998 AIDS RESE A R C H Alliance. All rights reserved. Gregory S. Britt AIDS RESEARCH Alliance Chief Executive Officer 621A North San Vicente Blvd. West Hollywood, CA 90069 Telephone: (310) 358-2423 Fax: (310) 358-2431 @ PRINTED BY ACUPRINT ON RECYCLED PAPER W I N T E R ’ 9 8 / ’ 9 9 S E A R C H L I G H T NEW C L I N I C A L T R I A L S 3 A nucleotide reverse-transcriptase inhibitor Gilead’s PMPA Prodrug A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients.