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A Community Perspective on SMART

A Community Perspective on SMART. Richard Jefferys Coordinator, Michael Palm Basic Science, Vaccines & Prevention Project. Historical, Personal Perspective.

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A Community Perspective on SMART

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  1. A Community Perspective on SMART Richard Jefferys Coordinator, Michael Palm Basic Science, Vaccines & Prevention Project

  2. Historical, Personal Perspective • AIDS Treatment Data Network, NYC: Provided low literacy treatment information (Simple Fact Sheets), NY State clinical trial directory, State ADAP & Medicaid database, NY State ADAP drug guide. National & State toll-free numbers. ~3,000 members • Post-1996, decline in calls for information & referrals, but population calling were those struggling the most with ARVs • Not surprisingly, great deal of interest in results of small trials suggesting CD4-guided ART interruption was safe • Bias toward assuming CD4-guided ART would be equivalent or superior to continuous

  3. Broader Community Interest in Treatment Interruptions • Structured Treatment Interruptions (STI) Workshop, July 30-August 1, 1999, Boston – co-sponsored by the Foundation for AIDS & Immune Research (FAIR), Project Inform and Treatment Action Group (TAG) • 2nd STI Workshop, October 13-15, 2000, Boston - FAIR, the Forum for Collaborative HIV Research, Project Inform and TAG • 3rd International STI Workshop, March 23-24 2002, Montréal - FAIR, the Forum for Collaborative HIV Research, Gay Men's Health Crisis, Project Inform and TAG

  4. Community Support for Large Simple Trials • Rescuing Accelerated Approval: Moving Beyond the Status Quo by Spencer Cox, Dennis Davidson, Gregg Gonsalves, Mark Harrington, Carlton Hogan, Rebecca Pringle Smith, September 12-13, 1994 • A Rationale for Large Simple Trials in AIDS by Carlton Hogan, PWA Alive and the University of Minnesota • CPCRA 065: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

  5. SMART Results • Jan 23, 2006 Clinical Alert: International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy • Response: • Denial • Something wrong with the data • Anger • It’s a pharmaceutical boondoggle • Bargaining • Maybe interruptions worked for some people (quality of life?) • Depression

  6. Acceptance • Immune activation=inflammation (not just T cell markers) • Inflammation=physiological harm • Ability of ART to prevent AIDS allows time for consequences of inflammation to manifest • Many assumptions about role of drug toxicity were wrong • Large simple trial design was critical in revealing what smaller trials could not • Unquantifiable amount of harm averted due to impact of the results on clinical trial designs and care

  7. Future Need for LSTs? • Community concern regarding immunological non-responders, and need to conduct clinical endpoint trials of interventions in this population • Adjuncts to ART, perhaps particularly in the aging HIV+ population e.g. anti-inflammatories • How will such trials be conducted & funded?

  8. Carlton Hogan, 1961-2003 Linda Grinberg, 1951-2002

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