Accepted for Publication: June 28, 2014.
Published Online: November 24, 2014. doi:10.1001/jamainternmed.2014.4010.
Study concept and design: Okulicz, Le, He, Ahuja.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Okulicz, Le, He, Ahuja.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Le, He, Ahuja.
Obtained funding: Agan, Ahuja.
Administrative, technical, or material support: Okulicz, Agan, Ganesan, Ferguson, He, Ahuja.
Study supervision: Ahuja.
Conflict of Interest Disclosures: Dr Wright reports receiving funding for consultancy to Abbott, Gilead Sciences, MSD, and ViiV as well as funds for unrestricted research from Abbott, Boehringer Ingelheim, Cilag, Gilead, and Janssen. Dr Smith reports receiving grant funding from Pfizer and ViiV and has served as a consultant for Genprobe. Dr Richman reports acting as a consultant for Biota Pharmaceuticals, Bristol-Myers Squibb, Chimerix, Gen-Probe, Gilead, Monogram Biosciences, Prism Pharmaceuticals, and Sirenas Marine Discovery. Dr Little reports receiving grant funding from Gilead. Dr Clark reports being a cofounder, equity holder, and uncompensated member of the scientific advisory board of Genkyotex, SA. No other disclosures were reported.
Funding/Support: The work was supported by the Veterans Affairs (VA) Research Center for AIDS and HIV Infection and VA Center for Personalized Medicine grant IP1 CX000875-01A1, National Institutes of Health (NIH) MERIT grant R37AI046326, and the Doris Duke Distinguished Clinical Scientist Award to Dr Ahuja. Dr Ahuja is also supported by a VA MERIT award, the Elizabeth Glaser Pediatric AIDS Foundation, the Burroughs Wellcome Clinical Scientist Award in Translational Research and the Senior Scholar Award from the Max and Minnie Tomerlin Voelcker Fund. This work was also supported by NIH grant UL1TR001120 (Clinical and Translational Science Award). Dr Le was supported by a VA Career Development Award–2. Dr Wright was supported by an Early Career Fellowship from the National Health and Medical Research Council of Australia. Support for this work was also provided in part by the Infectious Disease Clinical Research Program (IDCRP), a Department of Defense program executed through the Uniformed Services University of the Health Sciences (IDCRP-000-03). This project has been funded in part with federal funds from the National Institute of Allergy and Infectious Diseases, NIH, under Inter-Agency Agreement Y1-AI-5072. Drs Smith, Richman, and Little were supported by NIH grants DA034978, AI43638, AI69432, MH62512, AI74621, MH097520, AI077304, AI007384, AI080193, AI106039, and AI096113 and the International AIDS Vaccine Initiative grant DMS0714991.
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content of this publication is the sole responsibility of the authors and does not necessarily reflect the views or policies of the NIH or the Department of Health and Human Services, the Department of Defense, or the Departments of the Army, Navy, or Air Force. Mention of trade names, commercial products, or organizations does not imply endorsement by the US government.
Additional Contributions: We thank the study participants as well as the clinical and laboratory staff that made this work possible. Puraskar Ingale, MS, Muthu Manoharan, MS, Andrew Carrillo, BS, and Ella Koppelaar, MS, assisted with the graphics, and Gabriel Catano, MD (VA Research Center for AIDS and HIV-1 Infection and VA Center for Personalized Medicine, South Texas Veterans Health Care System, San Antonio, and Department of Medicine, The University of Texas Health Science Center) reviewed the manuscript. Scott Letendre, MD, Igor Grant, MD, and Robert K. Heaton, PhD (University of California, San Diego) provided access to CD4+ T-cell data from HIV seronegative participants enrolled in the HIV Neurobehavioral Research Center (P30 MH62512). None of these individuals received financial compensation.