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COUNTY OF SAN MATEO
Inter-Departmental Correspondence
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San Mateo Medical Center
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DATE:
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July 27, 2005
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BOARD MEETING DATE:
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August 16, 2005
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SPECIAL NOTICE/HEARING:
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None
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VOTE REQUIRED:
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Majority
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TO:
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Honorable Board of Supervisors
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FROM:
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Nancy J. Steiger, Chief Executive Officer, San Mateo Medical Center
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SUBJECT:
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Agreement with SmithKline Beecham Corporation dba GlaxoSmithKline (GSK)
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RECOMMENDATION:
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Adopt a Resolution:
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1.
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Accepting a grant from the SmithKline Beecham Corporation dba GlaxoSmithKline (GSK) in an amount not to exceed $226,861 to conduct a clinical trial evaluating the efficacy and safety of GW873140 in HIV-1 infected patients
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2.
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Authorizing the execution of an Agreement with SmithKline Beecham Corporation, dba GlaxoSmithKline (GSK), to conduct the clinical trial for the term May 23, 2005 until the trial is completed, in an amount not to exceed $226,861
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VISION ALIGNMENT:
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Commitment: Ensure Basic Health and Safety for All
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Goal(s): Provide residents access to healthcare and preventive care
The agreement contributes to this commitment and goal by continuing to pursue efforts to expand prevention activities through research and clinical studies. This study will assess the safety and effectiveness of GW873140 in R5-tropic and R5/X4-trop HIV-1 infected, treatment-experienced subjects with drug-resistant virus or an observational study in X4-tropic or non-phenotypeable HIV-1 infected, treatment-experienced subjects with drug-resistant virus.
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Performance Measure(s):
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Measure
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FY 2005-06
Projected
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FY2006-07
Projected
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FY2007-08
Projected
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Number of patients screened for enrollment into one of 3 arms of study GW873140
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30
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30
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30
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Percent of enrolled patients completing trial with a positive outcome
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75%
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75%
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75%
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A maximum of 30 clients will be enrolled in the study and followed over a three-year period. It is the goal that by the conclusion of the study, that 75% of enrolled patients will have a positive outcome from the medications provided in this study.
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BACKGROUND:
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The Clinical Trials and Research Unit of the San Mateo County Health Center was established by the Health Services Agency in 2000 in order to provide a mechanism and infrastructure for the conduct of clinical treatment trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment by the Unit staff identified HIV/AIDS as a problem affecting many of the County’s patients. The Clinical Trials and Research Unit discovered that patients are not responding to the current drug treatments. This trial will evaluate patient’s response to this new drug treatment.
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DISCUSSION:
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In April 2005 SmithKline Beecham Corporation dba GlaxoSmithKline contacted the Clinical Trials and Research Unit to participate in a clinical trial for patients with HIV/AIDS. On April 12, 2005, SmithKline Beecham Corporation dba GlaxoSmithKline notified the County that our site was selected to participate in the clinical trial. The County will receive up to $226,861 for patients, up to a maximum of 30 patients, enrolled into the study for fiscal year 2005-2006.
The primary purpose of this study is to evaluate the efficacy and safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 infected, treatment-experienced subjects with drug-resistant virus or an observational study in X4-tropic or non-phenotypeable HIV-1 infected, treatment-experienced subjects with drug-resistant virus.
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FISCAL IMPACT:
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The grant from SmithKline Beecham Corporation dba GlaxoSmithKline will not exceed $226,861. Funds will be included in the September budget revision. The term of the agreement is May 23, 2005 until the trial is completed. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research staff. There is no net county cost associated with this project.
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