메뉴 건너뛰기




Volumn 85, Issue 1, 2010, Pages 232-240

Running a tightrope: Regulatory challenges in the development of antiretrovirals

Author keywords

Accelerated approval; Clinical trial designs; Drug regulations; Expanded access; Fast track; HIV 1; PEPFAR; Resistance; Surrogate endpoint

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; AMPRENAVIR; ANTIRETROVIRUS AGENT; ATAZANAVIR; DARUNAVIR; DELAVIRDINE; DIDANOSINE; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ENFUVIRTIDE; FORTAVASE; FOSAMPRENAVIR; INDINAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; MARAVIROC; NELFINAVIR; NEVIRAPINE; RITONAVIR; SAQUINAVIR; STAVUDINE; TENOFOVIR DISOPROXIL; TIPRANAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZALCITABINE; ZIDOVUDINE;

EID: 73549117041     PISSN: 01663542     EISSN: 18729096     Source Type: Journal    
DOI: 10.1016/j.antiviral.2009.07.016     Document Type: Review
Times cited : (13)

References (43)
  • 1
    • 0033920318 scopus 로고    scopus 로고
    • A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn community programs for clinical research on aids
    • Baxter J.D., Mayers D.L., Wentworth D.N., Neaton J.D., Hoover M.L., Winters M.A., Mannheimer S.B., Thompson M.A., Abrams D.I., Brizz B.J., Ioannidis J.P., and Merigan T.C. A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn community programs for clinical research on aids. AIDS 14 (2000) F83-93
    • (2000) AIDS , vol.14
    • Baxter, J.D.1    Mayers, D.L.2    Wentworth, D.N.3    Neaton, J.D.4    Hoover, M.L.5    Winters, M.A.6    Mannheimer, S.B.7    Thompson, M.A.8    Abrams, D.I.9    Brizz, B.J.10    Ioannidis, J.P.11    Merigan, T.C.12
  • 3
    • 0027920523 scopus 로고
    • Update: Mortality Attributable to HIV Infection Among Persons Aged 25-44 Years - United States, 1991 and 1992
    • accessed July 21, 2009
    • Center for Disease Control (CDC), 1993. Update: Mortality Attributable to HIV Infection Among Persons Aged 25-44 Years - United States, 1991 and 1992. MMWR 42, 869-872. http://www.cdc.gov/mmwr/preview/mmwrhtml/00022174.htm (accessed July 21, 2009).
    • (1993) MMWR , vol.42 , pp. 869-872
  • 7
    • 0030567824 scopus 로고    scopus 로고
    • Delta: A randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals
    • the Delta Coordinating Committee
    • Darbyshire, J.H., the Delta Coordinating Committee, 1996. Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Lancet 348, 283-291.
    • (1996) Lancet , vol.348 , pp. 283-291
    • Darbyshire, J.H.1
  • 9
    • 73549105895 scopus 로고    scopus 로고
    • Etravirine. Raritan, NJ. Tibotec. 2008 (prescribing information). Tibotec Inc. INTELENCE (etravirine) tablet for oral use, prescribing information, revised 02/2008. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6580 (accessed June 11, 2009).
    • Etravirine. Raritan, NJ. Tibotec. 2008 (prescribing information). Tibotec Inc. INTELENCE (etravirine) tablet for oral use, prescribing information, revised 02/2008. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6580 (accessed June 11, 2009).
  • 12
    • 0031740223 scopus 로고    scopus 로고
    • Meta-analysis of antiretroviral effects on HIV-1 RNA, CD4 cell count and progression to AIDS or death
    • Hill A.M., DeMasi R., and Dawson D. Meta-analysis of antiretroviral effects on HIV-1 RNA, CD4 cell count and progression to AIDS or death. Antivir Ther. 3 (1998) 139-145
    • (1998) Antivir Ther. , vol.3 , pp. 139-145
    • Hill, A.M.1    DeMasi, R.2    Dawson, D.3
  • 14
    • 73549104777 scopus 로고    scopus 로고
    • Holmes, C., Coggin, W., Jamieson, D., Mihm, H., Savio, P., Hope, M., Ryan, C., Moloney-Kitts, M., Dybul, M., 2009. Measuring progress in reducing the costs of ARV drugs purchased by the President's Emergency Plan for AIDS Relief, 2005 to 2007. CROI 2009, 612. www.retroconference.org/2009/Abstracts/35741.htm (accessed July 16, 2009).
    • Holmes, C., Coggin, W., Jamieson, D., Mihm, H., Savio, P., Hope, M., Ryan, C., Moloney-Kitts, M., Dybul, M., 2009. Measuring progress in reducing the costs of ARV drugs purchased by the President's Emergency Plan for AIDS Relief, 2005 to 2007. CROI 2009, 612. www.retroconference.org/2009/Abstracts/35741.htm (accessed July 16, 2009).
  • 15
    • 0024508058 scopus 로고
    • HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy
    • Larder B.A., Darby G., and Richman D.D. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science 243 (1989) 1731-1734
    • (1989) Science , vol.243 , pp. 1731-1734
    • Larder, B.A.1    Darby, G.2    Richman, D.D.3
  • 16
    • 34347354196 scopus 로고    scopus 로고
    • Efficacy and safty of tMS125 (etraviringe) in treatment-experienced HIV-1 infected patients in DUET-2: 24-week results from a randomized, double-blind, placebo-controlled trial
    • Lazzarin A., Campbell T., Clotet B., Johnson M., Katlama C., and Moll A. Efficacy and safty of tMS125 (etraviringe) in treatment-experienced HIV-1 infected patients in DUET-2: 24-week results from a randomized, double-blind, placebo-controlled trial. Lancet 370 (2007) 39-48
    • (2007) Lancet , vol.370 , pp. 39-48
    • Lazzarin, A.1    Campbell, T.2    Clotet, B.3    Johnson, M.4    Katlama, C.5    Moll, A.6
  • 17
    • 34347327010 scopus 로고    scopus 로고
    • Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1 infected patients in DUET-1: 24-week results from a randomized, double-blind, placebo-controlled trial
    • Madruga J.V., Cahn P., Grinsztejn B., Haubrich R., Lalezari J., and Mills A. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1 infected patients in DUET-1: 24-week results from a randomized, double-blind, placebo-controlled trial. Lancet 370 (2007) 29-38
    • (2007) Lancet , vol.370 , pp. 29-38
    • Madruga, J.V.1    Cahn, P.2    Grinsztejn, B.3    Haubrich, R.4    Lalezari, J.5    Mills, A.6
  • 18
    • 73549097488 scopus 로고    scopus 로고
    • Maraviroc. New London, CT, Pfizer, 2007 (prescribing information). Pfizer Inc., SELZENTRY (maraviroc) tablet, film coated for oral use, prescribing information, revised 12/2008. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8731 (accessed June 15, 2009).
    • Maraviroc. New London, CT, Pfizer, 2007 (prescribing information). Pfizer Inc., SELZENTRY (maraviroc) tablet, film coated for oral use, prescribing information, revised 12/2008. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8731 (accessed June 15, 2009).
  • 19
    • 0041336973 scopus 로고    scopus 로고
    • Congress, the FDA, and the fair development of new medications for children
    • Available at: http://pediatrics.aappublications.org/cgi/content/full/112/3/669
    • McKinney Jr. R.E. Congress, the FDA, and the fair development of new medications for children. Pediatrics 112 (2003) 669-670. http://pediatrics.aappublications.org/cgi/content/full/112/3/669 Available at: http://pediatrics.aappublications.org/cgi/content/full/112/3/669
    • (2003) Pediatrics , vol.112 , pp. 669-670
    • McKinney Jr., R.E.1
  • 21
    • 0032903843 scopus 로고    scopus 로고
    • The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs
    • Murray J.S., Elashoff M., Iacono-Connors L.C., Cvetkovich T.A., and Struble K.A. The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs. AIDS 13 (1999) 797-804
    • (1999) AIDS , vol.13 , pp. 797-804
    • Murray, J.S.1    Elashoff, M.2    Iacono-Connors, L.C.3    Cvetkovich, T.A.4    Struble, K.A.5
  • 23
    • 73549084494 scopus 로고    scopus 로고
    • Raltegravir. Whitehouse Station, NJ. Merck, 2007 (prescribing information). Merck & Co., Inc. ISENTRESS (raltegravir) tablet, film coated for oral use, prescribing information, revised 2/2009. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9335 (accessed June 15, 2009).
    • Raltegravir. Whitehouse Station, NJ. Merck, 2007 (prescribing information). Merck & Co., Inc. ISENTRESS (raltegravir) tablet, film coated for oral use, prescribing information, revised 2/2009. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9335 (accessed June 15, 2009).
  • 24
    • 10144258702 scopus 로고    scopus 로고
    • Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimetre. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS
    • Saravolatz L.D., Winslow D.L., Collins G., Hodges J.S., Pettinelli C., Stein D.S., Markowitz N., Reves R., Loveless M.O., Crane L., Thompson M., and Abrams D. Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimetre. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS. N. Engl. J. Med. 335 (1996) 1099-1106
    • (1996) N. Engl. J. Med. , vol.335 , pp. 1099-1106
    • Saravolatz, L.D.1    Winslow, D.L.2    Collins, G.3    Hodges, J.S.4    Pettinelli, C.5    Stein, D.S.6    Markowitz, N.7    Reves, R.8    Loveless, M.O.9    Crane, L.10    Thompson, M.11    Abrams, D.12
  • 25
    • 73549118762 scopus 로고    scopus 로고
    • Senate Report 107-79, 2001. Best Pharmaceuticals for Children Act. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_reports&docid=f:sr079.107.pdf (accessed May 18, 2009).
    • Senate Report 107-79, 2001. Best Pharmaceuticals for Children Act. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_reports&docid=f:sr079.107.pdf (accessed May 18, 2009).
  • 27
    • 20644469472 scopus 로고    scopus 로고
    • Antiretroviral therapies for treatment-experienced patients: current status and research challenges
    • Struble K., Murray J., Cheng B., Gegeny T., Miller V., and Gulick R. Antiretroviral therapies for treatment-experienced patients: current status and research challenges. AIDS 19 (2005) 747-756
    • (2005) AIDS , vol.19 , pp. 747-756
    • Struble, K.1    Murray, J.2    Cheng, B.3    Gegeny, T.4    Miller, V.5    Gulick, R.6
  • 29
    • 0000211665 scopus 로고
    • 21 CFR Part 201: Specific requirements on content and format of labeling for human prescription drugs; Revision of 'Pediatric Use' subsection in the labeling, final rule
    • Available at:, accessed on May 15, 2009
    • U.S. Food and Drug Administration (FDA), 1994. 21 CFR Part 201: specific requirements on content and format of labeling for human prescription drugs; Revision of 'Pediatric Use' subsection in the labeling, final rule. Federal Register, 59, 64240-64250. Available at: http://frwebgate4.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=868741362968+1+1+0&WAISaction=retrieve (accessed on May 15, 2009).
    • (1994) Federal Register , vol.59 , pp. 64240-64250
  • 30
    • 73549087390 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Antiviral Drugs Advisory Committee transcripts, July 14-16, Available at:, accessed July 13, 2009
    • U.S. Food and Drug Administration, Antiviral Drugs Advisory Committee transcripts, July 14-16, 1997. Available at: http://www.fda.gov/ohrms/dockets/ac/cder97t.htm#Antiviral%20Drugs%20Advisory%20Committee (accessed July 13, 2009).
    • (1997)
  • 31
    • 73549087829 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Modernization Act FDAMA, Available at:, accessed July 13, 2009
    • U.S. Food and Drug Administration Modernization Act (FDAMA), 1997. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm (accessed July 13, 2009).
    • (1997)
  • 32
    • 73549095740 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA), 1998. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Final Rule, 63 Fed. Reg. 66,632. Available at: www.fda.gov (accessed on May 27, 2009).
    • U.S. Food and Drug Administration (FDA), 1998. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Final Rule, 63 Fed. Reg. 66,632. Available at: www.fda.gov (accessed on May 27, 2009).
  • 33
    • 73549125441 scopus 로고    scopus 로고
    • of the Federal Food, Drug, and Cosmetic Act. Available at:, accessed May 29, 2009
    • U.S. Food and Drug Administration (FDA), 1999. Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act. Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049924.pdf (accessed May 29, 2009).
    • (1999) Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section , vol.505 A
  • 34
    • 73549113518 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Antiviral Drugs Advisory Committee transcript, January 11, Available at:, accessed July 13, 2009
    • U.S. Food and Drug Administration Antiviral Drugs Advisory Committee transcript, January 11, 2001. Available at: http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Anti-Viral (accessed July 13, 2009).
    • (2001)
  • 37
    • 73549084708 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Amendments Act of 2007. Title IV: Pediatric Research Equity Act of 2007, January 4, 2007 (Public Law 110-85). Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf (accessed May 4, 2009)
    • U.S. Food and Drug Administration Amendments Act of 2007. Title IV: Pediatric Research Equity Act of 2007, January 4, 2007 (Public Law 110-85). Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf (accessed May 4, 2009)
  • 38
    • 73549092907 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Code of Federal Regulations, Title 21, Part 312, Subpart E, revised April 1, 2009. Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses. Available at: +2+1+0&WAISaction=retrieve accessed July 13, 2009
    • U.S. Food and Drug Administration, Code of Federal Regulations, Title 21, Part 312, Subpart E, revised April 1, 2009. Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses. Available at: http://frwebgate1.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=51022462543+2+1+0&WAISaction=retrieve (accessed July 13, 2009).
  • 39
    • 73549102156 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Code of Federal Regulations, Title 21, Part 314, Subpart H, revised April 1, 2009. Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. Available at: +1+1+0&WAISaction=retrieve accessed July 13, 2009
    • U.S. Food and Drug Administration, Code of Federal Regulations, Title 21, Part 314, Subpart H, revised April 1, 2009. Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. Available at: http://frwebgate1.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=51039466299+1+1+0&WAISaction=retrieve (accessed July 13, 2009).
  • 40
    • 73549116992 scopus 로고    scopus 로고
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. PEPFAR Overview. http://www.pepfar.gov/press/81352.htm (accessed July 16, 2009).
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. PEPFAR Overview. http://www.pepfar.gov/press/81352.htm (accessed July 16, 2009).
  • 41
    • 73549083610 scopus 로고    scopus 로고
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. About PEPFAR, Treatment. http://www.pepfar.gov/about/c19384.htm (accessed July 16, 2009).
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. About PEPFAR, Treatment. http://www.pepfar.gov/about/c19384.htm (accessed July 16, 2009).
  • 42
    • 73549103796 scopus 로고    scopus 로고
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. Celebrating Life: Latest PEPFAR Results. http://www.pepfar.gov/documents/organization/115411.pdf (accessed July 16, 2009).
    • U.S. President's Emergency Plan for AIDS Relief (PEPFAR), 2009. Celebrating Life: Latest PEPFAR Results. http://www.pepfar.gov/documents/organization/115411.pdf (accessed July 16, 2009).
  • 43
    • 0003732386 scopus 로고    scopus 로고
    • accessed July 21, 2009
    • World Health Organization (WHO), 2003. The World Health Report, http://www.who.int/whr/2003/chapter1/en/index3.html (accessed July 21, 2009).
    • (2003) The World Health Report


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.