We thank the patients for their participation in this study.
In addition to the authors, the study team included the following members: Courtney Ashton, BS, MT, Frontier Science and Technology Research Foundation, Inc., Amherst, NY; Anthony Bloom, Frontier Science and Technology Research Foundation, Inc., Amherst, NY; Rob Camp, Global Community Advisory Board, Barcelona, Spain; David Currin, RN, CCRC, University of North Carolina at Chapel Hill, Chapel Hill, NC; Lisa Demeter, MD, University of Rochester Medical Center, Rochester, NY; Renard Descallar, Gilead Sciences, Inc., Foster City, CA; Bernadette Jarocki, MS, Frontier Science and Technology Research Foundation, Inc., Amherst, NY; Ana Martinez, RPh, National Institutes of Health, Division of AIDS, Bethesda, MD; Lori Mong-Kryspin, BS, MT (ASCP), Ohio State University, Columbus, OH; Gene Morse, PharmD, State University of New York at Buffalo, Buffalo, NY; Savita Pahwa, MD, University of Miami School of Medicine, Miami, FL; Keith Pappa, PharmD, GlaxoSmithKline, Inc., Research Triangle Park, NC; Sabina Pfister, RN, Gilead Sciences, Inc., Foster City, CA; Helen Patterson, LPN, The Miriam Hospital, Providence, RI; Richard Pollard, MD, University of California, Davis, Sacramento, CA; Ronald Reisler, MD, MPH, University of Maryland School of Medicine, Baltimore, MD; Nancy Shulman, MD, Roche, Palo Alto, CA; Kimberly Smith, MD, MPH, Rush-Presbyterian–St. Luke’s Medical Center, Chicago, IL;Gary Thal, MD, Bristol-Myers Squibb Company, Princeton, NJ; Joseph Timpone, MD, Georgetown University Medical Center, Washington, DC; Amanda Zadzilka, BS, Frontier Science and Technology Research Foundation, Inc., Amherst, NY.
Other investigators and contributors included the following: Sandra Navarro, MD, and Lillian Colon, RN, BSN, University of Miami (Site 901) CTU Grant #AI069477, ACTG Grant #AI27675, CFAR Grant #AI073961; Susan L. Koletar, MD, and Diane Gochnour, RN, The Ohio State University (Site 2301) CTU Grant #AI069474; Julie Hoffman, RN, and Edward Seefried, RN, UCSD (Site 701) CTU Grant #AI69432; Carl Fichtenbaum, MD, and Michelle Saemann, RN, University of Cincinnati (Site 2401) CTU Grant #AI069513; Donna Pittard, RN, and David Ragan, RN, MSN, University of North Carolina (Site 3201) CTU Grant #AI69423, CFAR Grant #AI50410, GCRC Grant #RR00046 and Grant #RR025747; Elizabeth Lindsey, RN, and Tamara James, BS, University of Alabama (Site 5801) CTU Grant # U01 AI069452-03, CCTS Grant #1UL1 RR025777-01; Graham Ray, RN, MSN, and Steven Johnson, MD, University of Colorado Health Sciences Center (Site 6101) CTU Grant #RR025780; P. Jan Geiseler, MD, and Connie A. Funk, RN, MPH, University of Southern California (Site 1201) CTU Grant #5U01 AI069428; Michael Morgan, FNP, and Brenda Jackson, RN, Vanderbilt Therapeutics CRS (Site 3652) CTU Grant #AI069439; Pablo Tebas, MD, and Aleshia Thomas, RN, University of PA, subunit of Children’s Hospital of Philadelphia (Site 6201) CTU Grant #U01 AI069467-03, CFAR Grant #5P30 AI045008-10; Ge-Youl Kim, RN, BSN, and Mark Rodriguez, RN, BSN, Washington University (Site 2101) CTU Grant #AI069495; Jorge L. Santana, MD, and Santiago Marrero, MD, University of Puerto Rico (Site 5401) CTU Grant #5U01 AI069415-03; Jane Norris, PA-C, and Sandra Valle, PA-C, Stanford University (Site 501) CTU Grant #AI69556; Gary Matthew Cox, MD, and Martha Silberman, RN, Duke University Medical Center (Site 1601) CTU Grant #5U01 AI069484-02; Sadia Shaik, MD, and Ruben Lopez, MD, Harbor-UCLA Medical Center (Site 603) CTU Grant #AI069424, GCRC Grant #M01-RR00425; Margie Vasquez, RN, and Demetre Daskalakis, MD, New York University/NYC HHC at Bellevue Hospital Center (Site 401) CTU Grant #AI069532; Valery Hughes, NP, and Christina Megill, PA, Cornell Chelsea (Site 7804) CTU Grant #AI69419, CSTC Grant #RR024996; Jessica Shore, BSN, and BabafemiTaiwo, MBBS, Northwestern University CRS (Site 2701) CTU Grant #AI069471; Mitchell Goldman, MD, and Molly Boston, RN, Indiana University (Site 2601) CTU Grant #UO1 AI025859; Jeffrey Lennox, MD, and Carlos del Rio, MD, The Ponce de Leon Center (A5802) CTU Grant #5U01 AI069418, CFAR Grant #P30 AI050409; Timothy W. Lane, MD, and Kim Epperson, RN, Moses H. Cone Memorial Hospital (Site 3203) CTU Grant #1U01 A1069423-01; Annie Luetkemeyer, MD, and Mary Payne, RN, UCSF (Site 801) CTU Grant #1U01 AI069502-01; Barbara Gripshover, MD, and Dawn Antosh, RN, Case Western Reserve University (Site 2501) CTU Grant #AI69501; Jane Reid RN, MS, APN-BC, and Mary Adams, RN, MPh, University of Rochester (Site 1101) CTU Grant #U01 AI069511, GCRC Grant #UL1 RR024160; Sheryl S. Storey, PA-C, and Shelia B. Dunaway, MD, University of Washington (Site 1401) CTU Grant #AI069434; Ilene Wiggins, RN, and Eric Zimmerman, RN, Johns Hopkins University (Site 201) CTU Grant #AI69465, CTSA Grant #U54 RR023561; Kimberly Y. Smith, MD, MPH, and Joan A. Swiatek, RN, APN, Rush University Medical Center (Site 2702) CTU Grant #5U01 AI069471; Joseph Timpone, MD, and Princy Kumar, MD, Georgetown University (Site 1008) CTU Grant #1U01 AI069494-01; Ardis Moe, MD, and Maria Palmer PA-C, UCLA Care Center (Site 601) CTU Grant #AI069424; Jon Gothing, RN, BSN, ACRN, and Joanne Delaney, RN, BSN, Brigham and Women’s Hospital, Boston, MA (Site 107) CTU Grant #AI069472; Kim Whitely, RN, and Robert Kalayjian, MD, Metro Health Center (Site 2503) CTU Grant #AI069501; Scott M. Hammer and Michael T. Yin, HIV Prevention & Treatment (Columbia University; Site 30329) CTU Grant #5U01 AI069470, Grant #1UL1 RR024156; Mamta Jain, MD, and Tianna Petersen, MS, UT Southwestern Medical Center at Dallas (Site 3751) CTU Grant #3U01 AI046376 05S4; Roberto Corales, DO, and Christine Hurley, RN, AIDS Community Health Center (Site 1108) CTU Grant #U01 AI069511, GCRC Grant #UL1 RR024160; Keith Henry, MD, and Bette Bordenave, RN, Hennepin County Medical Center (Site 1502) Grant #N01 AI72626; Amanda Youmans, NP, and Mary Albrecht, MD, Beth Israel Deaconess (Partners/Harvard) CRS (Site 103) CTU Grant #UOI A106947203; Richard B. Pollard, MD, and Abimbola Olusanya, NP, University of California, Davis Medical Center (Site 3851) Grant #AI38858; Paul R. Skolnik, MD, and Betsy Adams, RN, Boston Medical Center CRS (Site 104) CTU Grant #AI069472; Helen Patterson, LPN, The Miriam Hospital-Brown University (Partners/Harvard; Site 2951) CTU Grant #1U01 AI069472-01; Michelle Ukwu and Lauren Rogers, Peabody Health Center (Site 31443) CTU Grant #AI069471; Henry H. Balfour Jr., MD, and Kathy A. Fox, RN, MBA, University of Minnesota (Site 1501) CTU Grant #AI27661; Susan Swindells, MBBS, and Frances Van Meter, APRN, University of Nebraska Medical Center (Site 1505) CTU Grant #AI27661; University of Hawaii (Site 5201) CTU Grant #AI34853; Gregory Robbins, MD, and Nicole Burgett-Yandow, RN, BSN, Massachusetts General Hospital from the Partners/Harvard/BMC ACTU (Site 101) CTU Grant #1U01 AI069472-01; Charles E. Davis Jr., MD, and Colleen Boyce, RN, IHV Baltimore Treatment CRS (Site 4651) CTU Grant #5U01 AI069447 03; William A. O’Brien, MD, and Gerianne Casey, RN, University of Texas Medical Branch (Site 6301) CTU Grant #AI032782; Gene D. Morse, PharmD, and Chiu-Bin Hsaio, MD, SUNY- Buffalo (Site 1102) CTU Grant #5U01 A1027658; San Mateo County AIDS Program (Site 505) CTU Grant #AI27666; Jeffrey L. Meier, MD, and Jack T. Stapleton, MD, University of Iowa Healthcare (Site 1504) NIAID Grant #AI27661 and Grant #AI58740; Donna Mildvan, MD, and Manuel Revuelta, MD, Beth Israel Medical Center ACTU (Site 2851) CTU Grant #AI46370; David Currin, RN, Wake County HHS (Site 30076) CTU Grant #AI25868; Wafaa El Sadr, MD, MPH, MPA, and Avelino Loquere, RN, Harlem ACTG CRS (Site 31483) CTU Grant #5U01 AI069470-03; Nyef El-Daher, MD, and Tina Johnson, RN, McCree McCuller Wellness Center (Site 1107) CTU Grant #U01 AI069511, GCRC Grant #UL1 RR024160; Robert Gross, MD, MSCE, and Kathyrn Maffei, RN, BSN, University of Pennsylvania Health (Site 6206) CTU Grant #1U01 AI69467-01; Deborah McMahon, MD, and Barbara Rutecki, CRNP, MPH, University of Pittsburgh (Site 1001) CTU Grant #1UO1 AI069494-01; Michael Wulfsohn, MD, PhD, Andrew Cheng, MD, PhD, Michael Miller, PhD, and Norbert Bischofberger PhD, Gilead Sciences; Sara Hughes, PhD, GlaxoSmithKline, Inc.
The human subjects committees of all sites approved the A5202 protocol and written informed consent was obtained from all participants in compliance with human experimentation guidelines of the US Department of Health and Human Services.
This work was supported by Award Number U01AI068636
from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), along with the previous grant number for the AIDS Clinical Trials Group (ACTG) Central Group, AI38858
, and the Statistical and Data Management Center (SDMC) grant, AI68634
. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID or the NIH. Also supported in part by the General Clinical Research Center Units funded by the National Center for Research Resources. Abbott Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, and GlaxoSmithKline provided the study medications.
Potential conflicts of interest.
All authors: No reported conflicts.
All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.