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Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Oclassen Clinical Trial R89-001-01
Pages 51-54

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From page 51...
... At the time that this protocol was developed, ganciclovir, which requires intravenous administration, had just become licensed; foscarnet, another intravenous drug with anti-CMV activity, was just beginning Phase IT clinical trials. The need to identify an effective oral drug to treat CMV disease in this patient population was one of the most important scientific priorities of the ACTG.
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From page 52...
... Corey, likewise, is a clinician-scientist who has extensive experience studying herpes-related viruses in the laboratory as well as experience studying the use of nucleoside agents in the treatment of both herpesvirus infections and HIV. Corey also had participated in the seminal studies of zidovudine for advanced HIV disease and was one of the lead investigators in studies which evaluated vidarabine and acyclovir for the treatment of herpesvirus infections.
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From page 53...
... In addition to the fax data summaries and conference calls, the interim results and protocol amendments were reviewed and approved by the ACTG Viral Pathogen Study Group and the ACTG Opportunistic Infection Core Committee. Therefore, data safety review was conducted both internally among the study team and externally through an independent peer review process for both the R89 and R90 studies.
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From page 54...
... The fourth patient, patient 107, died 11 weeks after receiving his last dose of FIAC. The 1993 FDA task force report classifies this case as one in which FIAC treatment should be considered a possible cause of death, but even in retrospect, although FIAC may have contributed to the observed liver failure, the confounding variables of CMV, hepatitis B and continuing treatment of HIV with zidovudine clearly preclude unequivocal classification of this death.
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Key Terms

  • conference calls
  • virus infections
  • viral dna
  • data summaries
  • clinical trials

  • study team
  • fda task
  • pathogen study
  • lead investigators
  • core committee

  • advanced hiv
  • hiv disease
  • infection core
  • composite data
  • experience studying

  • oclassen pharmaceuticals
  • data assessment
  • opportunistic infection
  • safety data
  • gastrointestinal disturbances

  • established bench
  • patient developed
  • hiv epidemic
  • intrahepatic cholestasis
  • experiences caused

  • recommended discontinuation
  • veterans administration
  • dna polymerase
  • force report
  • icds included


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