Access the full text.
Sign up today, get DeepDyve free for 14 days.
D. Donnell (2019)
Current and Future Challenges in Trial Design for Pre-Exposure Prophylaxis in HIV PreventionStatistical Communications in Infectious Diseases, 11
C. Andrews, W. Spreen, H. Mohri, Lee Moss, S. Ford, A. Gettie, K. Russell-Lodrigue, R. Bohm, C. Cheng‐Mayer, Zhi Hong, M. Markowitz, D. Ho (2014)
Long-Acting Integrase Inhibitor Protects Macaques from Intrarectal Simian/Human Immunodeficiency VirusScience, 343
S. Seifert, D. Glidden, Amie Meditz, J. Castillo-Mancilla, E. Gardner, J. Predhomme, Caitlin Rower, Brandon Klein, B. Kerr, L. Guida, Jia-Hua Zheng, Lane Bushman, P. Anderson (2014)
Dose response for starting and stopping HIV preexposure prophylaxis for men who have sex with men.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 60 5
George Greene, Gregory Swann, A. Fought, A. Carballo-Diéguez, T. Hope, P. Kiser, B. Mustanski, R. D’Aquila (2017)
Preferences for Long-Acting Pre-exposure Prophylaxis (PrEP), Daily Oral PrEP, or Condoms for HIV Prevention Among U.S. Men Who Have Sex with MenAIDS and Behavior, 21
Kathrine Meyers, Kristina Rodriguez, A. Brill, Yumeng Wu, M. Mar, D. Dunbar, B. Koblin, D. Margolis, M. Sobieszczyk, Hong-Van Tieu, I. Frank, M. Markowitz, S. Golub (2018)
Lessons for Patient Education Around Long-Acting Injectable PrEP: Findings from a Mixed-Method Study of Phase II Trial ParticipantsAIDS and Behavior, 22
J. Balkus, E. Brown, T. Palanee, G. Nair, Zakir Gafoor, Jingyang Zhang, B. Richardson, Z. Chirenje, J. Marrazzo, J. Baeten (2016)
An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African WomenJournal of Acquired Immune Deficiency Syndromes (1999), 72
This study presents an alternate index for comparing the effectiveness of two active agents. It has an intuitive basis and may allow for more power assessment of noninferiority
A. Nel, Neliëtte Niekerk, S. Kapiga, L. Bekker, C. Gama, Katherine Gill, A. Kamali, P. Kotze, C. Louw, Z. Mabude, Nokuthula Miti, Sylvia Kusemererwa, H. Tempelman, H. Carstens, B. Devlin, Michelle Isaacs, M. Malherbe, Winél Mans, Jeremy Nuttall, M. Russell, Smangaliso Ntshele, Marlie Smit, Leonard Solai, Patrick Spence, J. Steytler, Kate Windle, Maarten Borremans, S. Resseler, J. Roey, W. Parys, T. Vangeneugden, B. Baelen, Z. Rosenberg (2016)
Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women.The New England journal of medicine, 375 22
D. Dunn, D. Glidden, Oliver Stirrup, S. McCormack (2018)
The averted infections ratio: a novel measure of effectiveness of experimental HIV pre-exposure prophylaxis agents.The lancet. HIV, 5 6
M. Markowitz, I. Frank, R. Grant, K. Mayer, R. Elion, D. Goldstein, C. Fisher, M. Sobieszczyk, J. Gallant, Hong Tieu, W. Weinberg, D. Margolis, Krischan Hudson, B. Stancil, S. Ford, P. Patel, Elizabeth Gould, A. Rinehart, Kimberly Smith, W. Spreen (2017)
Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial.The lancet. HIV, 4 8
Mtn Team (2016)
Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in WomenThe New England Journal of Medicine, 375
J. García-Lerma, R. Otten, S. Qari, E. Jackson, M. Cong, S. Masciotra, W. Luo, C. Kim, D. Adams, Michael Monsour, Jonathan Lipscomb, Jeffrey Johnson, D. Delinsky, R. Schinazi, R. Janssen, T. Folks, W. Heneine, A. Carr, St 's (2008)
Prevention of Rectal SHIV Transmission in Macaques by Daily or Intermittent Prophylaxis with Emtricitabine and TenofovirPLoS Medicine, 5
P. Anderson, D. Glidden, A. Liu, S. Buchbinder, J. Lama, J. Guanira, V. McMahan, Lane Bushman, M. Casapia, Orlando Montoya-Herrera, V. Veloso, K. Mayer, S. Chariyalertsak, M. Schechter, L. Bekker, E. Kallás, R. Grant (2012)
Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with MenScience Translational Medicine, 4
Demonstrating the impact of novel PrEP methods : adding tiles to the mosaic
J. Sugarman, C. Celum, D. Donnell, K. Mayer (2019)
Ethical considerations for new HIV prevention trials.The lancet. HIV
A. Adimora, S. Cole, J. Eron (2017)
US Black Women and Human Immunodeficiency Virus Prevention: Time for New Approaches to Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 65 2
The Future of ARV-Based Prevention and More
H. Scott, E. Vittinghoff, Risha Irvin, A. Liu, LaRon Nelson, C. Rio, M. Magnus, S. Mannheimer, Sheldon Fields, Hong Tieu, I. Kuo, S. Shoptaw, B. Grinsztejn, Jorge Sanchez, S. Wakefield, J. Fuchs, D. Wheeler, K. Mayer, B. Koblin, S. Buchbinder (2019)
Development and Validation of the Personalized Sexual Health Promotion (SexPro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United StatesAIDS and Behavior, 24
(2019)
The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis
Michael Rayment (2011)
Prevention of HIV-1 infection with early antiretroviral therapyJournal of Family Planning and Reproductive Health Care, 38
J. Robins, M. Hernán, B. Brumback (2000)
Marginal Structural Models and Causal Inference in EpidemiologyEpidemiology, 11
C. Andrews, Y. Yueh, W. Spreen, Leslie Bernard, Mar Boente-Carrera, K. Rodriguez, A. Gettie, K. Russell-Lodrigue, J. Blanchard, S. Ford, H. Mohri, C. Cheng‐Mayer, Zhi Hong, D. Ho, M. Markowitz (2015)
A long-acting integrase inhibitor protects female macaques from repeated high-dose intravaginal SHIV challengeScience Translational Medicine, 7
O. Laeyendecker, R. Brookmeyer, M. Cousins, C. Mullis, J. Konikoff, D. Donnell, C. Celum, S. Buchbinder, G. Seage, G. Kirk, S. Mehta, J. Astemborski, L. Jacobson, J. Margolick, Joelle Brown, T. Quinn, S. Eshleman (2013)
HIV incidence determination in the United States: a multiassay approach.The Journal of infectious diseases, 207 2
Elizabeth Irungu, R. Heffron, N. Mugo, K. Ngure, E. Katabira, N. Bulya, E. Bukusi, J. Odoyo, S. Asiimwe, E. Tindimwebwa, C. Celum, J. Baeten, Jared Haug, J. Baeten, C. Celum, R. Heffron, D. Donnell, R. Barnabas, J. Haberer, Harald Haugen, C. Hendrix, L. Kidoguchi, M. Marzinke, Susan Morrison, J. Morton, N. Ware, Monique Wyatt, E. Katabira, N. Bulya, E. Bukusi, J. Odoyo, N. Mugo, K. Ngure (2016)
Use of a risk scoring tool to identify higher-risk HIV-1 serodiscordant couples for an antiretroviral-based HIV-1 prevention interventionBMC Infectious Diseases, 16
V. Fonner, Sarah Dalglish, C. Kennedy, R. Baggaley, K. O'reilly, Florence Koechlin, M. Rodolph, I. Hodges-Mameletzis, R. Grant (2016)
Effectiveness and safety of oral HIV preexposure prophylaxis for all populationsAIDS (London, England), 30
UNAIDS Data
S. Davis, J. Hines, M. Habel, J. Grund, R. Ridzon, Brittney Baack, J. Davitte, A. Thomas, Valerian Kiggundu, N. Bock, P. Pordell, Caroline Cooney, Irum Zaidi, C. Toledo (2018)
Progress in voluntary medical male circumcision for HIV prevention supported by the US President’s Emergency Plan for AIDS Relief through 2017: longitudinal and recent cross-sectional programme dataBMJ Open, 8
(2018)
Adaptive noninferiority margins under observable nonconstancy
C. Mullick, J. Murray (2020)
Correlations between HIV infection and rectal gonorrhea incidence in men who have sex with men: Implications for future HIV pre-exposure prophylaxis trials.The Journal of infectious diseases
This study reviews the ethical landscape for designing trials in the 2019 era of HIV prevention
R. Landovitz, Sue Li, B. Grinsztejn, H. Dawood, A. Liu, M. Magnus, M. Hosseinipour, R. Panchia, L. Cottle, G. Chau, P. Richardson, M. Marzinke, C. Hendrix, S. Eshleman, Yinfeng Zhang, E. Tolley, J. Sugarman, Ryan Kofron, A. Adeyeye, D. Burns, A. Rinehart, D. Margolis, W. Spreen, M. Cohen, M. McCauley, J. Eron (2018)
Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trialPLoS Medicine, 15
This study considers designs for next-generation PrEP agents including designs which randomized PrEP decliners in a placebo controlled trial
Cohen (2011)
Prevention of HIV-1 infection with early antiretroviral therapyN Engl J Med, 365
Downloaded from http://journals.lww.com/co-hivandaids by BhDMf5ePHKbH4TTImqenVA5KvPVPZ0P5BEgU+IUTEfzO/GUWifn2IfwcEVVH9SSn on 06/02/2020 REVIEW URRENT Statistical approaches to accelerate the PINION development of long-acting antiretrovirals for HIV pre-exposure prophylaxis David V. Glidden Purpose of review This review considers statistical issues in the design and analysis of the studies used to develop long-acting formulations of antiretrovirals for pre-exposure prophylaxis (PrEP). Recent finding An abundant pipeline of products is maturing. Accelerating their evaluation as clinical products requires abandonment of noninferiority standards. Randomized trials should be based on the comparison of principled but innovative estimates of background HIV risk and enrich enrollment for those who do not desire current PrEP products. At every stage of testing, innovative analyses can be applied to help inform and accelerate later studies. Summary The development of new long-acting PrEP regimens can be accelerated by innovations in design, ingenuity in synthesizing data sources, and application of causal inference methods. Keywords HIV prevention, implant, long-acting injectable, noninferiority, pre-exposure prophylaxis INTRODUCTION Formative data for phase III trials While the present technologies to control the HIV Animal studies have been used in the proof of epidemic are promising, the prevention movement concept for the effectiveness of potential PrEP is falling far short of its goal. In
Current Opinion in HIV & AIDS – Wolters Kluwer Health
Published: Jan 1, 2020
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.