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PAPERBACK list:$56.50 Web:$50.85 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Preventing HIV Infection among Injecting Drug Users in High Risk Countries: An Assessment of the Evidence Scaling Up Treatment for the Global AIDS Pandemic: Challenges and Opportunities Other Related Titles Methodological Challenges in Biomedical HIV Prevention Trials (2008) Board on Global Health (BGH) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 234   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix B Acronyms AIDS acquired immunodeficiency syndrome ANRS Agence Nationale de Recherche sur le Sida (France) ANVISA Brazilian National Health Vigilance Agency ART antiretroviral therapy AVAC AIDS Vaccine Advocacy Coalition CAPRISA Centre for the AIDS Program of Research in South Africa CDC Centers for Disease Control and Prevention (U.S.) CMED Medicines Market Regulation Chamber DMC Data Monitoring Committee DSMB Data Safety Monitoring Board EIA enzyme immunoassay ELISA Enzyme-Linked ImmunoSorbent Assay EMEA European Agency for the Evaluation of Medicinal Products FDA Food and Drug Administration (U.S.) FHI Family Health International HIV human immunodeficiency virus HPTN HIV Prevention Trials Network HSV herpes simplex virus HVTN HIV Vaccine Trials Network IAVI International AIDS Vaccine Initiative IND Investigational New Drug application (to FDA, U.S.) IOM Institute of Medicine (U.S.) IPM International Partnership for Microbicides ITT intent-to-treat analysis MCC Medicines Control Council (South Africa) Page 234 Front Matter (R1-R12) Summary (1-26) Introduction (27-36) 1 The Status and Challenges of Biomedical HIV Prevention Trials (37-68) 2 Basic Design Features: Size, Duration, and Type of Trials, and Choice of Control Group (69-87) 3 Design Considerations: Risk-Reduction Counseling (88-103) 4 Design Considerations: Pregnancy (104-118) 5 Design Considerations: Adherence (119-147) 6 Design Considerations: Recruitment and Retention (148-159) 7 Site Preparedness (160-174) 8 Estimating HIV Incidence (175-185) 9 Interim Monitoring and Analysis of Results (186-203) 10 Alternative Designs (204-224) Appendix A: Public Committee Meeting Agendas (225-233) Appendix B: Acronyms (234-235) Appendix C: Supporting Materials for Chapter 2 (236-244) Appendix D: Methods for Analyzing Adherence (245-249) Appendix E: Committee Biographies (250-258)

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OCR for page 234
Methodological Challenges in Biomedical HIV Prevention Trials Appendix B Acronyms AIDS acquired immunodeficiency syndrome ANRS Agence Nationale de Recherche sur le Sida (France) ANVISA Brazilian National Health Vigilance Agency ART antiretroviral therapy AVAC AIDS Vaccine Advocacy Coalition CAPRISA Centre for the AIDS Program of Research in South Africa CDC Centers for Disease Control and Prevention (U.S.) CMED Medicines Market Regulation Chamber DMC Data Monitoring Committee DSMB Data Safety Monitoring Board EIA enzyme immunoassay ELISA Enzyme-Linked ImmunoSorbent Assay EMEA European Agency for the Evaluation of Medicinal Products FDA Food and Drug Administration (U.S.) FHI Family Health International HIV human immunodeficiency virus HPTN HIV Prevention Trials Network HSV herpes simplex virus HVTN HIV Vaccine Trials Network IAVI International AIDS Vaccine Initiative IND Investigational New Drug application (to FDA, U.S.) IOM Institute of Medicine (U.S.) IPM International Partnership for Microbicides ITT intent-to-treat analysis MCC Medicines Control Council (South Africa)

OCR for page 235
Methodological Challenges in Biomedical HIV Prevention Trials MDP Microbicides Development Programme MRC Medical Research Council MTN Microbicide Trial Network NIAID National Institute of Allergy and Infectious Diseases (U.S.) NIH National Institutes of Health (U.S.) PEP post-exposure prophylaxis PI principal investigator PrEP pre-exposure prophylaxis STD sexually transmitted disease STI sexually transmitted infection TDF tenofovir disoproxil fumarate UNAIDS The Joint United Nations Programme on HIV/AIDS USAID U.S. Agency for International Development WHO World Health Organization