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Sangamo Biosciences Inc. Message Board

  • bruce.ribble bruce.ribble Sep 13, 2009 11:37 PM Flag

    U of Penn consent form for SB-728

    U of Penn SB-728 consent form
    This document covers 4/22/09 to 11/18/09 and pp. 3 has a nice timeline picture showing 10 weeks from 1st test to infusion and 18 weeks from 1st test to end of step 2. It provides all the details of the study of course.

    Here's the links to cohort 1 and 2.

    http://www.uphs.upenn.edu/pennactu/trials/consents/Sangamo Cohort 1.pdf

    http://www.uphs.upenn.edu/pennactu/trials/consents/Sangamo Cohort 2.pdf

    InformedConsentFormandHIPAAAuthorization

    Version 6: 04-06-09 Page 1 of 16

    UNIVERSITY OF PENNSYLVANIA

    RESEARCH SUBJECT

    INFORMED CONSENT FORM and HIPAA

    Authorization

    Study Sponsored By: The University of Pennsylvania

    Protocol Title: A Phase I Study of Autologous T-Cells Genetically

    Modified at CCR5 gene by Zinc Finger Nucleases SB-728

    in HIV-Infected Subjects (Cohort 1)

    Principal

    Investigator:

    Pablo Tebas, M.D.

    Dept. of Medicine, Div of Infectious Diseases

    (ID)

    3400 Spruce Street

    Philadelphia, PA 19104

    Tel: 215-662-6932

    On pp.6 of the cohort 2 document I thought this paragraph raised the question, How do they know? I am probably misinterpreting it and is probably used to cover all the legal bases. Be great if it turns out to be prophetic:

    "Once the drug holiday begins, you will then be asked to return to the clinic every two weeks for two months (4 visits). One month after this, you will be asked to undergo a rectal biopsy procedure before you will restart anti-HIV medication, and will return monthly until no virus is detected in your blood. This may take one month, or several months, but it typically takes only one to two months. If prior to the scheduled time to restart your HIV medication, the physician finds that your HIV is found above 100,000 copies per ml or your CD4 cell counts drops to 350 or below, you will be told, and your study doctors will recommend that you restart the same HIV medications that you were taking before starting the planned drug holiday."

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