Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Appendix A: Chronology of FIAU/FIAC Clinical Trials
Appendix A: Chronology of FIAU/FIAC Clinical Trials
Pages 155-164
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Appendixes
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August- R89 Protocol modified, approved by ACTG committees, CMV Study October Group, Opportunistic infection Committee, NTAID Medical Branch and University of Washington and UCSD's TRBs. October R89 12- Meeting between Oclassen and FDA.
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and the Acting Clinical Director, MAID. R90 ~ 9- UW HSRC application approved, "Tolerance of HTV Infected Patients to Oral Doses of FlAU".
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2 lowering dose to 0.5 mg/kg. R90 5- The NTAID TRB recommends approval pending compliance with ~ stipulations.
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992 February R91 Protocol R9 ~ -0 ~ 0 submitted to FDA. March R91 26- Approval received from the FDA subject to changes in consent form language, use of DNA polymerase activity rather than just HBV DNA as a means of monitoring therapy, and a change in doses.
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(FDA ~ 993 Task Force suggests this death possibly FlAU related, but notes that the presence of multiple hepatitis virus infections limits nnssihie concl,,rion~ chant FlA1J toxicity.) PPPC 21- Lilly summarizes results of R90, R91 trials at meeting with FDA, lays out future plans.
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Hoofnagle a copy of the newly revised FIAU Clinical Investigators's Brochure that includes the FDA's modifications in the informed consent documents. March PPPC 5- After the PI responds to the IRB's stipulations, the Chair, NIDDK IRB approves the amended protocol.
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PPPC 5- Patient #3D (Lilly #001-2002) dies of Lactic acidosis and cardiovascular collapse one day after an unsuccessful liver transplantation.
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PPPC 31- Patient #6C dies of multiorgan failure. September PPPC 22- The Director, OHSR wrote to OPRR providing all available documentation regarding the protocol and informing that office that review of the materials indicated that the protocol had been conducted in accord with the terms and conditions of the NIH Multiple Project Assurance.
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