CAB MEETING MINUTES

November 25, 2003  

Four CAB members, 4 staff members and 1 guest attended the November 2003 meeting of the UTMB Galveston AIDS Clinical Trials Unit Community Advisory Board (CAB). 

Report from Dr. Roberts

Dr. David Wohl’s name has been withdrawn as a potential PI candidate; he has decided to remain at the University of North Carolina.  The search for a permanent PI continues. 

Entries into interventional protocols were down for October and November at our site. 

Little progress has been made in getting new studies approved for inmate inclusion within the TDCJ.    HIV-infected inmates are effectively being denied access to suitable treatment protocols due to what amounts to continued delays and bureaucracy with TDCJ’s internal approval process, which was revamped last year.  It took 5 and 6 months for the TDCJ to review the last two ACTG protocols submitted.  These protocols were subsequently closed early by the sponsor due to low accrual so when TDCJ approval was finally given, it was all in vain.  

Protocol Reviews 

Dr. Tanvir Bell presented information on ACTG A5163, which has recently opened to enrollment for HIV-infected men and women, ages 25 and older, with low bone mineral density.  Fosamex (alendronate) and calcium are standard therapy for treatment and prevention of osteoporosis in post-menopausal women.  The study is being done to see if people with HIV and weak bones would benefit from the same treatment.  To reduce the potential for esophageal irritation (known complication), alendronate should be taken with a full glass of water and patients should not lie down for at least 30 minutes after dosing.  

Dr. Daryl Lau discussed a recently released site draft for a new HIV-HCV coinfection treatment study -- ACTG A5178, SLAM-C:  Suppressive Long-Term Antiviral Management of Hepatitis C Virus and HIV-1 in Coinfected Subjects.  She presented background information on the spectrum of HCV disease, the challenges in treating HCV Genotype 1, which is most prevalent in the U.S and the least responsive to treatment, and evolution of treatment for HCV.  A5178 would extend PEG-IFN and ribavirin treatment for subjects who fail to achieve HCV sustained virologic response to at least 12 weeks of any interferon-based therapy.  One item she would question the team on is the need for a second liver biopsy three months after study entry if a biopsy was done at entry.   

New Business 

Carrie suggested reviewing/planning outreach events at the January meeting.  Letter to CAB mail recipients requesting updated contact information to go out in January.  

No meeting in December – Happy holidays & new year!

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