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Glossary


ALT:

alanine aminotransferase, an enzyme present in liver cells and a marker of liver injury when present in quantity in the blood

amylase:

an enzyme that catalyzes the hydrolysis of starch into smaller molecules

ascites:

retention of fluid in the abdomen

AST:

aspartate aminotransferase, an enzyme present in liver cells and a marker of liver injury when present in quantity in the blood

AZT:

zidovudine, formerly known as azidothymidine, a synthetic thymidine analog that inhibits the human immunodeficiency virus that causes AIDS


CAH:

chronic active hepatitis

CFR:

Code of Federal Regulations

cholangiolitis:

inflammation of cholangioles, one of the fine terminal elements of the bile duct system

cholestasis:

stoppage or suppression of the flow of bile, having intrahepatic or extrahepatic causes

chorioretinitis:

inflammation of the choroid and retina

choroid:

the thin, pigmented, vascular coat of the eye; it furnishes the blood supply to the retina and conducts arteries and nerves to the anterior structures

cirrhosis:

liver disease characterized pathologically by loss of the normal microscopic lobular architecture, with fibrosis and nodular regeneration

CMV:

cytomegalovirus, a pathogen that causes chronic disease in immunocompromised but not immunocompetent patients

coagulation:

the process of clot formation

CRF:

clinical report form, used to record patient data, in summary form, in clinical trials


ddC:

dideoxycytidine, a nucleoside analog used in the treatment of human immunodeficiency virus infection

ddI:

dideoxyinosine, a nucleoside analog used in the treatment of human immunodeficiency virus infection

didanosine:

ddI


encephalopathy:

any degenerative disease of the brain



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OCR for page 266
Review of the Fialuridine (FIAU) Clinical Trials Glossary ALT: alanine aminotransferase, an enzyme present in liver cells and a marker of liver injury when present in quantity in the blood amylase: an enzyme that catalyzes the hydrolysis of starch into smaller molecules ascites: retention of fluid in the abdomen AST: aspartate aminotransferase, an enzyme present in liver cells and a marker of liver injury when present in quantity in the blood AZT: zidovudine, formerly known as azidothymidine, a synthetic thymidine analog that inhibits the human immunodeficiency virus that causes AIDS CAH: chronic active hepatitis CFR: Code of Federal Regulations cholangiolitis: inflammation of cholangioles, one of the fine terminal elements of the bile duct system cholestasis: stoppage or suppression of the flow of bile, having intrahepatic or extrahepatic causes chorioretinitis: inflammation of the choroid and retina choroid: the thin, pigmented, vascular coat of the eye; it furnishes the blood supply to the retina and conducts arteries and nerves to the anterior structures cirrhosis: liver disease characterized pathologically by loss of the normal microscopic lobular architecture, with fibrosis and nodular regeneration CMV: cytomegalovirus, a pathogen that causes chronic disease in immunocompromised but not immunocompetent patients coagulation: the process of clot formation CRF: clinical report form, used to record patient data, in summary form, in clinical trials ddC: dideoxycytidine, a nucleoside analog used in the treatment of human immunodeficiency virus infection ddI: dideoxyinosine, a nucleoside analog used in the treatment of human immunodeficiency virus infection didanosine: ddI encephalopathy: any degenerative disease of the brain

OCR for page 266
Review of the Fialuridine (FIAU) Clinical Trials FIAC: fiacitabine, a pyrimidine nucleoside analog originally synthesized by Fox and his colleagues at Memorial Sloan-Kettering cancer center to be used in the treatment of herpes group virus infections (See figure 1, chapter 4) FIAU: fialuridine, the principal metabolite of FIAC, also a pyrimidine nucleoside analog flare: a rise in serum aminotransferases (AST and/or ALT) prior to normalization of liver enzymes, frequently associated with clearance of hepatitis B virus from the liver Gilbert's syndrome: an inborn error of bilirubin metabolism, probably autosomal dominant, a benign elevation of unconjugated bilirubin with no liver damage or hematologic abnormalities glomerulonephritis: a variety of nephritis (inflammation of the kidney) characterized by inflammation of the capillary loops in the glomeruli of the kidney half-life: the time that it takes for the concentration of drug in plasma or the amount of drug in the body to be reduced by 50 percent HBV: hepatitis B virus HCC: hepatocellular carcinoma HCV: hepatitis C virus hepatic steatosis: fatty deposits in the liver hepatocellular steatosis: fatty deposits within or around hepatocytes hepatocyte: a parenchymal liver cell, an essential element of the organ hepatotoxicity: the quality or property of exerting a destructive or poisonous effect liver cells HIV: human immunodeficiency virus hyperbilirubinemia: excessive concentrations of bilirubin in the blood, which may lead to jaundice hypoalbuminemia: an abnormally low albumin content of the blood H3X-MC-PPPA: FIAU study conducted on five hepatitis B virus-positive subjects at the New England and Galveston sites, sponsored by Eli Lilly. Referred to in this report as Trial PPPA. H3X-MC-PPPC: FIAU study conducted on 15 hepatitis B virus-positive subjects at the National Institutes of Health Clinical Center, sponsored by Eli Lilly. Referred to in this report as Trial PPPC. H3X-MC-PPPG: FIAU study conducted on 17 healthy males at the Lilly Laboratory for Clinical Research, sponsored by Eli Lilly. Referred to in this report as Trial PPPG. ICD: informed consent document IND: investigational new drug application interferon: a naturally occurring protein produced by lymphocytes and fibroblasts in response to chronic viral infection which has been used in the treatment of chronic hepatitis B virus infection since the 1970s IRB: institutional review board jaundice: yellowish skin

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Review of the Fialuridine (FIAU) Clinical Trials lactic acidosis: severe and rapidly progressing accumulation of lactic acid in the blood laparoscopic cholecystectomy: surgical removal of the gall bladder leukopenia: reduction in the number of leukocytes in the blood, the count being 5,000 or less lipase: glycerol-ester hydrolase; any of a group of widely occurring enzymes that catalyze the hydrolysis of ester linkages between the fatty acids and glycerol of the triglycerides and phospholipids macrovesicular steatosis: accumulation of fat droplets around the cells of an organ membranoproliferative glomerulonephritis: a chronic glomerulonephritis characterized by the mesangial cell proliferation and irregular thickening of the glomerular capillary wall microvesicular steatosis: accumulation of fat droplets within the cells of an organ morbidity: the extent and frequency of disease symptoms and their impacts on daily activities mortality: the frequency with which infection results in death murine: pertaining to or affecting rats or mice myelosuppression: suppression of bone marrow activity, resulting in a reduction in the number of platelets, red cells, and white cells myopathy: damage to the muscles in the arms and legs NAI (No Action Indicated) letter: from the Office of Compliance of the Food and Drug Administration to the investigators and/or sponsors to inform them that violations have been identified but that no action is required NDA: new drug application neuralgia: paroxysmal pain that extends along the course of one or more nerves neutropenia: a decrease in the number of neutrophilic leukocytes in the blood nucleoside analog: molecules similar to the building blocks of deoxyribonucleic acid [DNA] that become incorporated into the viral DNA as the virus divides, inhibiting and interrupting this replicative machinery NIAID: National Institute of Allergy and Infectious Diseases NIDDK: National Institute of Diabetes and Digestive and Kidney Diseases OAI (Official Action Indicated) letter: from the Office of Compliance of the Food and Drug Administration to investigators and/or sponsors intending to warn them of an impending action and that requires a response within 15 working days OPPR: Office for Protection from Research Risks pancreatitis: inflammation of the pancreas pancytopenia: deficiency of all cell elements of the blood; aplastic anemia pathogen: a specific cause (bacterium or virus) of a disease peripheral neuropathy: damage to the nerves in the arms and legs Phase I study: Usually the first stage in testing an investigational new drug application to the Food and Drug Administration, done to generate preliminary information on the chemical action and safety of the new drug, and it is usually not controlled

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Review of the Fialuridine (FIAU) Clinical Trials Phase II study: Usually the second stage of testing it is carried out on persons having the disease or condition of interest, determining the efficacy of the drug along with providing information on safety Phase III study: Usually the third and final stage of testing; it is concerned with assessment of dosage effects, efficacy, and safety, the design usually includes a control treatment, and the drug manufacturer or sponsor may request permission to market the drug for the indication or condition covered in the testing proteinuria: An excess of serum proteins in the urine; also called albuminuria protocol: the plan or schedule of events to be followed in a study or investigation or in an intervention program R89-001: FIAC study conducted on 12 human immunodeficiency virus-positive/cytomegalovirus positive subjects at the University of Washington and University of California at San Diego, sponsored by Oclassen Pharmaceuticals. Abbreviated throughout this report as R89. R90-001: FIAU study conducted on 42 immunodeficiency virus - positive/cytomegalovirus positive subjects at the University of Washington, University of California at San Diego, and the National Institutes of Health Clinical Center, sponsored by Oclassen Pharmaceuticals. Abbreviated throughout this report as R90. R91-010: FIAU study conducted on 24 immunodeficiency virus - positive/cytomegalovirus positive subjects at the National Institutes of Health Clinical Center, sponsored by Oclassen Pharmaceuticals. Abbreviated throughout this report as trial R91. SGOT: serum glutamic oxaloacetic transaminase; older term for AST SGPT: serum glutamic pyruvic transaminase; older term for ALT steatosis: fatty deposits subcutaneous: under the skin thrombocytopenia: decrease in the number of blood platelets transaminase: aminotransferase; class of enzymes present in serum and in various body tissues, especially in the heart and liver and released into the serum as a result of tissue injury VAI (Voluntary Action Indicated) letter: from the Office of Compliance of the Food and Drug Administration that requests a response from the investigators and/or sponsors within 30 working days of receipt with a proposal for correcting or preventing future problems or deviations varices: an enlarged and tortuous vein, artery, or lymphatic vessel VZV: varicella-zoster virus WHV: woodchuck hepatitis virus zidovudine: azidothymidine (AZT), a nucleoside analog used in the treatment of human immunodeficiency virus infections