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FF Principal Investigator/Program Director (Last, first, middle): Katzenstein, David A. BIOGRAPHICAL SKETCH Provide the following information for the key personnel in the order listed for Form Page 2. Photocopy this page or follow this format for each person. NAME David Katzenstein POSITION TITLE Associate Professor of Medicine Associate Director, Stanford ACTU EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) INSTITUTION AND LOCATION University of California, San Diego, San Diego, CA University of California, San Diego School of Medicine University of California, San Diego University of California, Davis, Davis, CA DEGREE (if applicable) YEAR(s) B.A. M.D. 1973 1977 1980 1983 FIELD OF STUDY Biology Medicine Fellowship/ID Fellowship/ID RESEARCH AND PROFESSIONAL EXPERIENCE: A. Positions and Honors. Positions and Employment 1982-1984 Assistant Clinical Professor of Medicine, Division of Infectious Disease, University of California, Davis and Martinez Veterans Administration Hospital, Martinez, CA. 1982-1984 Assistant Professor of Medicine, Division of Infectious Diseases, University of Minnesota. 1986-1987 Lecturer, Department of Medical Microbiology, Godfrey Huggins School of Medicine, University of Zimbabwe. 1987-1989 Senior Research Fellow, Laboratory of Retrovirus Research, Center for Biologics Evaluation and Research, Food and Drug Administration. 1989-1990 Clinical Assistant Professor of Medicine, Division of Infectious Diseases, Stanford University, and Associate Director, Stanford University AIDS Clinical Trials Group. 1990-1997 Assistant Professor of Medicine, Division of Infectious Diseases, Stanford University, and Associate Medical Director, Stanford University AIDS Clinical Trials Group. 1997-present Associate Professor of Medicine, Division of Infectious Diseases, Stanford University Other Experience and Professional Memberships 1992- present Associate Director, Stanford University AIDS Clinical Trials Group. 1992 -1996 Associate Director, Stanford Clinical Virology Laboratory 1996- present Director, Stanford University Advanced Technology Laboratory 1995-2000 Member, HIV Disease Research Agenda Committee, ACTG 1995-2001 Member, University of California Universitywide Task Force on AIDS 1999-2002 Chair, HIV Resistance Web Board of Scientific Advisors 2000- present Chair, Biologic Outcome working Group, NIMH C-pol study 1996 International AIDS Society – USA antiretroviral panel 1988 Infectious Disease Society of America 2001HIV Medicine Association 2001 Rockefeller AIDS Care and Treatment Antiretroviral Working Group 2001 International Physicians in AIDS Care, faculty Honors 2000 Doris Duke Charitable Foundation , Distinguished Clinical Scientist Award PHS 398 (REV. 5/95) (Form Page 6) Page Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. FF SELECTED BIBLIOGRAPHY 1. Katzenstein DA, Hammer SM, Hughes MD, Gundacker H, Jackson JB, Fiscus S, Rasheed S, Elbeik T, Reichman R, Japour A, Merigan TC. The relation of virologic and immunologic markers to clincial outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. New England J. Med, 1996; 335 (15): 1091-8. 2. Goulston C, McFarland W, Katzenstein DA. Human immunodeficiency virus type 1 RNA shedding in the female genital tract. Journal of Infectious Diseases, 1998; 177 (4): 1100-1103. 3. Rey D, Hughes M, Pi JT, Winters M, Merigan TC, Katzenstein DA. HIV-1 reverse transcriptase codon 215 mutation in plasma RNA: immunologic and virologic responses to zidovudine. The AIDS Clinical Trials Group 175 Virology Team. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 1998; 17 (3): 203-208. 4. Zijenah L, Mbizvo MT, Kasule J, Nathoo K , Munjoma M, K, Mahomed K , Maldonado Y, Madzime S, and Katzenstein D. Mortality in the first 2 years among infants born to HIV-infected women in Harare, Zimbabwe. Journal of Infectious Diseases, 1998; 178 (1):109-113. 5. Simpson D, Katzenstein DA, Hughes MD, Hammer SM, Williamson DL, Jiang Q, Pi JT. Neuromuscular function in HIV infection: analysis of a placebo-controlled combination antiretroviral trial. AIDS Clinical Group 175/801 Study Team. AIDS, 1998; 12 (18): 2425-2432. 6. Winters MA,Coolley KL, Girard YA, Levell DJ, Hamdan H, Shafer RW, Katzenstein DA, Merigan TC. A 6basepair insert in the reverse transcriptase gene of human immunodeficiency virus type 1 confers resistance to multiple nucleoside inhibitors. J Clin Invest, 1998; 102 (100: 1769-75. 7. Gregson S, Machekano R, Donnell CA, Mbizvo MT, Anderson RM, Katzenstein DA. Estimating HIV incidence from age-specific prevalence data: comparison with concurrent cohort estimates in a study of male factory workers, Harare, Zimbabwe. AIDS, 1998; 12 (15): 2049-58. 8. Marschener IC, Collier AC, Coombs RW, D'Aquilla RT, DeGruttola V, Fishcl MA, Hammer SM, Hughes MD, Johnson VA, Katzenstein DA, Richman DD, Smeaton LM, Spector SA, Saag MS. Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess clinical benefit of antiretroviral therapy. J Infect Dis, 1998; 177 (1): 40-47. 9. Lathey JL, Hughes MD, Fiscus SA, Pi T, Jackson JB, Rasheed S, Elbeik T, Reichman R, Japour A, D'Aquila RT, Scott W, Griffith BP, Hammer SM, Katzenstein DA. Variability and prognostic values of virologic and CD4 cell measures in human immunodeficiency virus type 1-infected patients with 200-500 CD4 cells/mm(3) (ACTG 175). AIDS Clinical Trials Group Protocol 175 Team. J Infect Dis, 1998; 177 (3): 617-624. 10. Watts H, Spino C, Zaborski L, Katzenstein D, Hammer S, Benson C. Comparison of gynecologic findings in HIV positive women with CD4 counts between 200 and 500 and below 100. JAIDS, 20 (5): 455-62, 1999. 11. Shafer RW, Chaung T, Hsu P, White CB, Katzenstein DA. Sequence and drug susceptibility of subtype C protease from human immunodeficiency virus type 1 seroconverters in Zimbabwe, AIDS Res Hum Retro, 1999; 15 (1): 65-69. 12. Tien PC, Chiu T, Latif A, Ray S, Batra M, Contag CH, Zejenah L, Mbizvo M, Delwart EL, Mullins JI, Katzenstein DA. Primary Subtype C HIV-1 Infection in Harare, Zimbabwe. J Acquired Imm Def Syndr Hum Retro 1999; 20 (2): 147-153. 13. Katzenstein D, Mbizvo M, Zijeneh L, Gittens T, Munjoma M, Hill D, Madzime S, and Maldonado Y. Serum level of maternal human immunodeficiency virus (HIV) RNA, infant mortality, and vertical transmission of HIV in Zimbabwe. Journal of Infectious Diseases, 1999; 179 (6): 1382-1387. 14. Shulman NS, Zolopa AR, Passaro D, Shafer RW, Huang W, Katzenstein DA, Israelski DM, Hellmann N, Petropoulos C, Whitcomb J. Phenotypic hyper-susceptibility of non-nucleoside reverse transcriptase inhibitors in treatment experienced HIV-infected patients: impact on virological response to efavirenz-based therapy. AIDS. 2001 Jun 15;15(9):1125-32. PHS 398 (REV. 5/95) (Form Page 6) Page Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. FF 15. J. Lathey, C. Tierney, S. Chang, R. D’aquila, D. Bettendorf, H. Alexander, C. Santini, A. Hughes, C. Barroga, S. Spector, J. Landes, S. Hammer, D. Katzenstein, and the ACTG 175 Virology Team* for the AIDS Clinical Trials Group, NIAID, Bethesda, MD. Associations of CCR5, CCR2, and SDF-1 Genotypes with Disease Progression and Response to ARVs in Asymptomatic Patients in ACTG 175. J Infect Dis 2001; 184:1402-11. 16. Shulman, NS, Shafer RA, Winters M, Machekano R, Zolopa AR, Hughes M, Katzenstein DA Genotypic correlates of a virologic response to stavudine after zidovudine monotherapy. J Acquir Immune Defic Syndr. 2001 Aug 1;27(4):377-80. 17. Albrecht MA, Bosch R, Hammer S, Liou S-H, Kessler H, Para M, Eron J, Valdez H, Dehlinger M, Katzenstein DA. Nelfinavir, Efavirenz or both after failure of nucleoside treatment of HIV infection. New Engl J Med 2001;345:398-407 18. Simpson DM, Katzenstein DA, Haidich AB, Schifitto G, Yiannoutsos CT, Geraci AP, McArthur JC, ACTG 291 study team. Severity of symptoms of DSPN related to HIV-1 RNA plasma viral load Neurology 2001. 19. Albrecht MA, Bosch R, Hammer S, Liou S-H, Kessler H, Para M, Eron J, Valdez H, Dehlinger M, Katzenstein DA. Nelfinavir, Efavirenz or both after failure of nucleoside treatment of HIV infection. New Engl J Med 2001;345:398-407. 20. Miriam Rabkin, Wafaa El-Sadr, David Katzenstein, Kevin M. De Cock, Joia Mukherjee, Henry Masur, Peter Mugyenyi, Paula Munderi and Janet Darbyshire. Antiretroviral therapy in resource-poor settings: Clinical research priorities. Lancet 2002; 360: 1503–05. 21. D. A. Katzenstein1, R. J. Bosch, N Hellmann3, N Wang2, L Bacheler4, M. A. Albrecht. Phenotypic Susceptibility And Virologic Outcome In Nucleoside-Experienced Patients Receiving Three Or Four Antiretrovirals. AIDS 2003; 17:821-830. 22. Mark A.Winters, Ronald J. Bosch, Mary A. Albrecht, and David A. Katzenstein for the ACTG 364 Study Team Clinical Impact of the M184V Mutation on Switching to Didanosine or Maintaining Lamivudine Treatment in Nucleoside-Experienced Patients. J Infect Dis. 2003 Aug 15;188(4):537-40. 23. Rami Kantor, Solomon Mutetwa, Lynn Zijenah, Elizabeth Johnston, Robert Lloyd, Andrea von Lieven, Dennis Israelski, Robert W. Shafer and David A. Katzenstein. HIV-1 subtype C reverse transcriptase and protease genotypes in patients from Zimbabwe failing ARV Aids Research And Human Retro 2002; 18: 1407–1413. 24. Camlin Tierney, Janet L. Lathey, Cindy Christopherson, Daniel M. Bettendorf, Richard T. D'Aquila, Scott M. Hammer, David A. Katzenstein, and the ACTG 175 Virology Team . Prognostic Value of Baseline HIV-1 DNA Measurement for HIV Disease Progression in Patients Receiving Nucleoside Therapy. Journal of Infectious Diseases 2003; 187:144–8. 25. Kantor R, Katzenstein D.Polymorphism in HIV-1 non-subtype B protease and reverse transcriptase and its potential impact on drug susceptibility and drug resistance evolution. AIDS Rev. 2003 Jan-Mar;5(1):25-35. 26. Elizabeth R. Johnston, Lynn S. Zijenah, Solomon Mutetwa, Rami Kantor, Chonticha Kittinunvorakoon, and David A. Katzenstein. High Frequency of Syncytia inducing and CXCR4 tropic viruses among HIV-1 Subtype C infected patients receiving antiretroviral treatment. J Virol 2003;77(13):7682-8. 27. Ronald J. Bosch; Gerald F. Downey; David A. Katzenstein; Nicholas Hellmann; Lee Bacheler; Mary A. Albrecht; for the ACTG 364 Study Team.Evaluation of cutpoints for phenotypic hypersusceptibility to efavirenz. AIDS 17 (research notes): 2395-2396; Apr 2003 28. Mark A.Winters, Ronald J. Bosch, Mary A. Albrecht, and David A. Katzenstein for the ACTG 364 Study Team Clinical Impact of the M184V Mutation on Switching to Didanosine or Maintaining Lamivudine Treatment in Nucleoside-Experienced Patients. J Infect Dis. 2003 Aug 15;188(4):537-40. 29. Jiang H, Deeks SG, Kuritzkes DR, Lallemant M, Katzenstein D, Albrecht M, DeGruttola V. Assessing resistance costs of ARV therapies via measures of future drug options. J Infect Dis. 2003 Oct 1;188(7):1001-8. 30. Courtney V. Fletcher, Hongyu Jiang,Richard C. Brundage, Edward P. Acosta, Richard Haubrich, David Katzenstein,Roy M. Gulick. Sex Differences in Saquinavir Pharmacology and Virologic Response in AIDS Clinical Trials Group (ACTG) Study 359. The Journal of Infectious Diseases 2004;189:1176-1184. PHS 398 (REV. 5/95) (Form Page 6) Page Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. FF PHS 398 (REV. 5/95) (Form Page 6) Page Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. FF