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Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Oclassen Clinical Trial R90-001-01 (NIH Protocol 91-AI-0031)
Pages 55-60

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From page 55...
... The development of R90-001-01 was very similar to the development of RS9. Multiple meetings and conference calls within the AIDS Clinical Trials Group system reviewed draft protocols, including reviews by representatives from the Medical Branch of the National Institute of Allergy and Infectious Diseases (NIATD)
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From page 56...
... Like Douglas Richman and Lawrence Corey, Straus had been integrally involved in the development of drugs designed to treat human herpesvirus infections, such as vidarabine and acyclovir. Straus is also a bench research scientist with special interest in the pathogenesis of herpes simplex virus disease.
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From page 57...
... Several patients in the R90 study developed elevations in liver function enzyme levels while on treatment. Most notably, patients 216, 221, and 224 exhibited two- to three-fold elevations in transaminase values in the second or third week of the study.
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From page 58...
... After 2 weeks of follow-up the patient missed all further appointments at NTH. The patient's HIV medication was switched from AZT to dd} in July by his local physician, and 6 weeks later he developed fulminant hemorrhagic pancreatitis, ascribed to the ddI in combination with his HBV and HIV infections.
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From page 59...
... COMMENT Like the R89 trial, this was a carefully performed Phase ~ clinical study that underwent extensive internal and external peer review prior to initiation. The real-time data and safety assessments via fax and conference calls once again resulted in remarkably efficient identification of an MTD and modification of the protocol into a dose-deescalating study, with a shift in focus from the study of CMV disease to one of HBV infection.
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From page 60...
... Therefore he could quite appropriately be judged as having died as a result of his underlying hepatic disease, which was a result of hepatitis C and D virus infections as well as HBV infection. Patient 406 clearly died from severe pancreatitis.
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Key Terms

  • transaminase levels
  • ddi therapy
  • conference calls
  • hbv infection
  • dna levels

  • clinical trials
  • chronic hbv
  • liver function
  • circulating hbv
  • lactic acidosis

  • total dose
  • dna polymerase
  • stephen straus
  • laboratory values
  • virus infections

  • alt levels
  • hemorrhagic pancreatitis
  • dosage level
  • gastrointestinal symptoms
  • patient receiving

  • enzyme levels
  • third patient
  • significant gastrointestinal
  • unexpected adverse
  • hbv disease

  • pathogen study
  • extensive cirrhosis
  • periodically visited
  • patient continued
  • displayed recrudescence


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