Important note: Information in this article was accurate in March 2000. The state of the art may have changed since the publication date.
Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 14, Number 3/4, Spring 2000
A community meeting, Long-Term Effectiveness Clinical Trials in HIV/AIDS, met in San Francisco on January 29, 2000, the day before the Retrovirus Conference began. Approximately 50 activists met in response to the NIH's workshop on long-term studies in HIV infection that was held in Bethesda on January 12 and 13. The NIH workshop addressed the following questions: What are the high priority clinical questions to be addressed through long-term clinical studies in the era of HAART? What is the role of cohort studies and randomized clinical trials in addressing long-term clinical questions? What are the statistical challenges and alternative approaches in addressing long-term clinical questions? There were also breakout sessions on when to start, when to switch, and long-term clinical efficacy and tolerability of HAART.
Participants of the NIH workshop provided summaries and led discussions of how the HIV/AIDS community should respond. As might be expected, everyone agreed that data on long-term treatment of HIV/AIDS — including information about toxicities and side effects, quality of life, treatment strategies (especially when to start and when to switch), and coinfections — would be valuable. However, there was less consensus when it came to logistics. For instance, which questions would require large, randomized trials, and how large would they have to be? What role could observational studies play? Would changes in treatment make the results obsolete? How difficult would it be to enroll participants? What should the clinical endpoints be? Ethical concerns about equipoise, determining the standard of care, and informed consent were also raised, as was the importance of getting input from a more diverse and representative group. Some, however, felt that money would be better spent on smaller trials focusing on more specific questions.
Since this meeting, a Long-Term Effectiveness Research (LTER) Focus Group has formed to address these and other issues. It has issued the following consensus statement, which GMHC and a large number of other organizations have signed.
Every day thousands of people living with HIV agonize over questions about whether or not to begin antiretroviral therapy:
And, along with almost everyone already on antiretrovirals, they worry about drug complications and resistance.
Are the answers to these questions different for women and men? For different ethnicities? For different age groups? How about those with additional diseases, such as hepatitis, diabetes, cardiovascular disease or addiction disorders?
These are issues that will affect the lives and health of hundreds of thousands of people, involve billions of dollars in annual medication and other health care costs, and influence the standards of HIV care for decades.
Yet there is precious little scientific data to help us make these decisions.
We, the undersigned, call on the National Institutes of Health to address this situation immediately.
NIH must immediately commit significant financial and organizational resources to research these questions and develop, as expeditiously as possible, a detailed plan for that research. We are years behind where we should be and the lives and health of many are increasingly at risk.
As a first step in this process, NIH should immediately consult with a variety of advisors — including members of the HIV/AIDS community, researchers, clinicians, statisticians, and members of the pharmaceutical industry — to begin development of a long-term clinical research plan.
We insist upon full and immediate community participation in all stages of planning this research, utilizing the experience, knowledge and commitment of HIV/AIDS community activists reporting back to the larger affected community.
We call on NIH to demonstrate leadership and expedite the design and funding of long-term effectiveness research to answer these priority questions:
It is important that the answers are relevant to as many people living with HIV as possible including women, the elderly, adolescents, African Americans, Hispanics, and other ethnic groups as well as those living with hepatitis, diabetes, or other life-complications.
NIH must confront its institutional biases and restrictions and provide creative, collaborative and flexible leadership in conducting trials that will certainly be larger and longer than those it has traditionally conducted for HIV/AIDS.
The length and size of these studies, as well as the great importance of the answers for determining proper standards of care for HIV treatment, require extraordinary efforts for recruitment and retention.
Not every question may require a randomized clinical trial. Some, such as the elucidation of long-term complications and toxicities of antiretroviral therapy, may be better answered with observational databases.
Yet, NIH is ultimately responsible for guaranteeing that these questions will be answered in an efficient, ethical and scientifically rigorous manner.
Too much time has already been lost. The risk of continued delay is too great. We call on NIH to act now.
20000310
GM140302
Copyright © 2000 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011 fredg@gmhc.org http://www.gmhc.org
ÆGiS is made possible through unrestricted grants from Roxane Laboratories, Inc., iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.
ÆGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1990, 2000. ÆGiS & the Sisters of Saint Elizabeth of Hungary. All materials appearing on ÆGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS and the Sisters of Saint. Elizabeth of Hungary, or the party credited as the provider of the content.