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Suggested Citation:"Appendix B: Acronyms." Institute of Medicine. 2008. Methodological Challenges in Biomedical HIV Prevention Trials. Washington, DC: The National Academies Press. doi: 10.17226/12056.
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Page 234
Suggested Citation:"Appendix B: Acronyms." Institute of Medicine. 2008. Methodological Challenges in Biomedical HIV Prevention Trials. Washington, DC: The National Academies Press. doi: 10.17226/12056.
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Page 235

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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) 234

APPENDIX B 235 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

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The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results.

According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.

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