Community Sign-On Letter: Continue the SMART Trial

January 27, 2006

We are seeking sign-ons (from organizations, but also individuals) for a letter requesting community input into the future of the SMART Trial and consideration of its continuation as a large, diverse, multinational cohort. The letter is copied below.

Please send sign-on information (name/organization name, city, state, country) to Nita Costello (, Research & Treatment Advocate at The Center for AIDS Information and Advocacy. Sign-ons are due by 5 pm Eastern Time on Friday, February 3.

Anthony Fauci, M.D.
Director, National Institute of Allergy and Infectious Disease
National Institutes of Health (NIH)
31 Center Drive, Building 31, Room 7A03
Bethesda, MD 20892

[DATE], 2006

Dear Dr. Fauci,

As advocates for the HIV/AIDS community in areas of research and treatment, we step forward now to demand that the SMART trial, an international study with more than 5,000 people enrolled, be allowed to continue as a large, prospective cohort that could yield valuable data on patient care, treatment strategies, comorbidities, etc. The study, which is being conducted by the Community Programs for Clinical Research on AIDS (CPCRA), was designed to compare intermittent, CD4-guided antiretroviral therapy to continuous antiretroviral therapy. Announcements of the discontinuation of enrollment in the "interruption" group and rollover of all patients to continued therapy are being misinterpreted as an end to the study. The community insists on being given input on how to best utilize information from the study and whether or not to continue SMART as a large, observational cohort.

This large, diverse, multinational study could still provide answers to valuable questions, even now that only the viral suppression arm remains. The network and communication structure is in place to follow one of the largest cohorts of patients ever assembled. Significant resources have already been devoted to this trial. To end an effort such as this in an attempt to save money in a funding-challenged time such as this would truly be a mistake given the long-term, clinical endpoint data that this cohort can provide. The field of HIV/AIDS does not have such data, in fact we are long overdue for such data. Smaller cohorts of gay, white men cannot substitute for a large cohort as rich and diverse as SMART. In fact, some might even suggest that enrollment in the antiretroviral therapy arm continue for the purpose of growing the cohort.

We have known for quite some time that there are risks associated with taking medication interruptions. But the benefits from continuous therapy must be weighed against the side effects and toxicities (both acute and long-term) associated with antiretroviral treatment. Quality of life matters greatly as well. As approaches to antiretroviral therapy continues to evolve, we desperately need information regarding survival, comorbidities, adverse events, and much more. Rather than recommend solutions at this point, we suggest that a cross-cutting dialogue begin so that we can determine the best ways to proceed with this potentially invaluable resource for research and characterization of HIV disease over time and in a large, diverse population.

The following are merely some suggestions on ways we might use the rich information this cohort could provide:

  1. We strongly urge the continued following of SMART study participants so that valuable information, such as long-term incidence of toxicity-related events, so light can be shed on this unfocused area of HIV/AIDS research.

  2. We strongly encourage the continuation of ongoing substudies being conducted such as neurologic complications, metabolic issues, and anal dysplasia.

  3. We strongly recommend that the National Institutes of Health (NIH) seek input from HIV/AIDS experts, advocates, and patients on how to best utilize the SMART data now and in the future to answer important questions about HIV disease and its management. Protocol amendments, subgroup analyses, and other approaches should be considered.

  4. We insist on the continued funding of the SMART study as being conducted through the CPCRA. We wholly deem the creation and following of a large, diverse, multi-national cohort of HIV-positive people as medically and scientifically worthwhile, if not absolutely necessary.

In closing, we would like to acknowledge the hard work and dedication of the organizers, researchers, clinicians, and participants in this study. In the aftermath of press releases and short-lived media Coverage, what we need are strategy and foresight to do the most meaningful research to help people living with HIV and AIDS around the world.


The Center for AIDS information & Advocacy, Houston, Texas

[other organizations as signed on below]

This article was provided by The Center for AIDS Information & Advocacy. Visit CFA's website to find out more about their activities and publications.


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