CRIA recently published its first edition of HIV/AIDS Clinical Trials: A Directory for New York State. This resource is being supported by a contract from the New York State Department of Health AIDS Institute and is being distributed free of charge to local medical and non-medical care providers. It offers the most comprehensive, up-to-date listing available of enrolling HIV trials within New York, New Jersey, Connecticut, and Philadelphia.
CRIA's grant required a thorough assessment of the previous directory on enrolling HIV trials published by another agency before we even started to design our new publication. The statewide assessment included input from both consumers and care providers to learn how they would change the document to make it more useful. These findings are reflected in HIV/AIDS Clinical Trials: A Directory for New York State.
Completely updated editions of the directory will be available every six months. CRIA will eventually offer listings of enrolling trials online at www.criany.org, which we will update regularly.
CRIA thanks HIV InSite at the University of California, San Francisco for their assistance in identifying trial sites, data development, and collection of information. Visit them online at http://hivinsite.ucsf.edu for a listing of HIV clinical trials nationally.
CRIA has created its third in a series of topic specific treatment education brochures for consumers nationwide, called Clinical Trials Explained.
Our new brochure was developed as part of the directory project described above. It is meant to complement the directory by providing consumers with an overview of the clinical trial process and information on the risks and benefits of participating in HIV clinical trials. In fact, the single most significant finding from the statewide assessment was that most patients and non-medical care providers don't know enough about the clinical research process to make informed decisions about considering trial participation. CRIA's new brochure will help address this issue.
While the directory itself is only for New York residents, CRIA has printed enough additional copies of the new brochure to ensure that clients of AIDS service organizations outside of our area can also benefit from the information contained within it. CRIA has already begun to distribute free bulk copies of Clinical Trials Explained to non-profits nationwide. As with all of our publications, the new brochure can also be read online at www.criany.org.
CRIA has begun its participation in a multi-site Serono Laboratories sponsored trial of Recombinant Human Growth Hormone (Serostim®) to treat lipodystrophy.
Back in 1998, CRIA conducted the first research of this agent to address the abnormal metabolic side effects afflicting PLWAs across the United States who are on antiretroviral therapies. Since then, our independent research in this area has become widely recognized as drawing attention to one of the few potentially beneficial treatments for lipodystrophy. As such, Serono Laboratories had decided to conduct more comprehensive research of Serostim needed for FDA approval of its use in correcting metabolic abnormalities in HIV patients. CRIA began enrolling patients in March.
This is a double blind, randomized triple arm trial where participants will either take the drug and placebo every other day, only the drug, or only the placebo daily over a 12-week period, followed by another 12-weeks on one of the alternative arms. Maximum dose will be 4mg of drug per day depending on an individual's height and weight, and six visits to CRIA's clinic will be required to perform sophisticated body measurement, blood tests, and glucose tolerance tests. All participants will have the opportunity to enroll in a maintenance phase of Serostim following the 24-week study period. For more information on this protocol, see the CRIA Trials in Progress section of CRIA Update.
After a long battle with AIDS and then ALS, CRIA volunteer and Community Advisory Board (CAB) member, Brian Schuman, died on February 22, 2001. Brian was an active supporter of CRIA's mission from very early on in our existence. He was among the first community members to not only contribute financially to CRIA's research program, but also to give of his time to help our staff develop and implement new programs. When he was well enough, he was at CRIA's clinic nearly every Tuesday. He also provided valuable contributions to agency policy-making discussions through his membership on our CAB.
Brian exemplified why CRIA has been and must continue to remain so dedicated to its research and education mission. His experience with HIV was extremely difficult, having to endure multiple hospitalizations for serious complications. Yet, he was always energized to fight hard for his life. When he finally was able to achieve some semblance of health stability through use of combination therapy, he was diagnosed with ALS. Throughout all of these challenging times, Brian remained firmly committed to helping others with dire medical circumstances by actively supporting CRIA's work. We will forever miss his humor and thoughtful guidance.
This article was provided by AIDS Community Research Initiative of America. It is a part of the publication CRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.