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Community Perspectives on the SMART Study and Its Impact on HIV Treatment Strategies

This document outlines the significant insights and community experiences surrounding the SMART study and its implications on HIV treatment. Coordinated by Richard Jefferys and Michael Palm, it discusses the evolution of treatment information accessibility post-1996, highlighting community concerns, biases, and interests in treatment interruptions. It details structured treatment interruptions workshops and community support for large simple trials, emphasizing the need for ongoing clinical trials to address issues faced by immunological non-responders and the aging HIV+ population. The legacy of influential figures like Carlton Hogan is also acknowledged.

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Community Perspectives on the SMART Study and Its Impact on HIV Treatment Strategies

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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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