74 Views | 31 Downloads
(T.S.U.), Email: tuldrick@fredhutch.org; (S.R.L.), Email: sharon.lewin@unimelb.edu.au
T.S.U., S.R.L., S.G.D., N.C., S.P.F., M.A.C., R.S., and R.Y. conceptualized the study. S.R.L., N.C., J.D.L., R.J.G., F.M., and M.R. contributed to the methodology. T.S.U., S.P.F., M.A.C., R.Y., P.H.G., K.L., R.R., H.C., L.O., and C.-c.J.W. conducted the clinical trial. A.R. and T.A.R. conducted and analyzed unspliced HIV RNA and HIV DNA experiments. R.F. conducted TILDA experiments. M.R. and C.T. conducted HIV sequencing and analysis. R.J.G. and J.L.W. conducted plasma HIV experiments. T.S.U., S.V.A., S.R.L., N.C., R.F., and M.A.C. analyzed data. S.V.A. and C.T. performed data visualization. All authors wrote, reviewed, and edited the manuscript.
We dedicate this manuscript to the memory of the late M. A. “Mac” Cheever, Principal Investigator of the CITN, who was instrumental in developing CITN-12. We thank the study participants; staff from the CITN: J. Kaiser, L. Lundgren, A. Claeys, A. Wright, B. Bertoldi, A. LaCroix, and D. Schullery; as well as CITN sites that enrolled participants in CITN-12 [National Cancer Institute (NCI) HIV and AIDS Malignancy Branch at the Center for Cancer Research, University of California San Francisco, Yale, Roswell Park, and Louisiana State University Health Science Center]. We also thank S. Townson, E. Chartash, and D. Kaufman from Merck as well as E. Sharon, W. Merritt, and R. Little from the NCI’s Cancer Treatment Evaluation Program. We thank A. Pagliuzza from Université de Montréal for technical assistance.
T.S.U., M.A.C., S.P.F., and R.Y. receive research support from Merck; T.S.U., R.R., K.L., and R.Y. receive research support from Celgene/Bristol-Myers Squibb; and R.R., K.L., and R.Y. receive research support from EMD Serano and CTI Biopharma, all through cooperative research and development agreements (CRADA) with the NCI. T.S.U. received research support from Roche through a clinical trial agreement with the Fred Hutchinson Cancer Research Center and consulted for AbbVie and Seattle Genetics. T.S.U. and P.H.G. are current employees of Regeneron and have stock options. R.Y. received drug for research from Janssen Pharmaceuticals under a material transfer agreement (MTA). T.S.U. and R.Y. are co-inventors on U.S. patent 10 001,483 titled “Methods for the treatment of Kaposi’s sarcoma or KSHV-induced lymphoma using immunomodulatory compounds and uses of biomarkers.” R.Y. is also a co-inventor on patents on a peptide vaccine for HIV (U.S. patent 9474793) and the treatment of Kaposi sarcoma with IL-12 (U.S. patents 6509321 and 6423308), and an immediate family member of R.Y. is a co-inventor on patents related to internalization of target receptors (U.S. patent 8420620), KSHV vIL-6 (U.S. patents 7374756, 7235365, 7108981, and 6939547), and the use of calreticulin and calreticulin fragments to inhibit angiogenesis (U.S. patent 7488711). All rights, title, and interest to these patents have been or should, by law, be assigned to the U.S. Department of Health and Human Services; the government conveys a portion of the royalties it receives to its employee inventors under the Federal Technology Transfer Act of 1986 (P.L. 99–502). S.R.L. has received investigator-initiated research funding from Merck, Gilead Sciences, Viiv, and Leidos and is a member of the scientific advisory boards of Merck, Viiv, Gilead, Immunocore, and Aelix. J.D.L. has received research funding from and served as a scientific advisor to Gilead Sciences. S.G.D. receives research support from Gilead and Merck; is a member of the scientific advisory boards for BryoLogyx, Enochian Biosciences, and Tendel; and has consulted for AbbVie, Eli Lilly, GSK/ViiV, and Immunocore. N.C. has received investigator-initiated research funding from Merck and EMD Serono. C.-c.J.W. has received investigator-initiated research support from Bristol-Myers Squibb. All other authors declare that they have no competing interests.
This study was funded in part by the Intramural Research Program of the National Institutes of Health (NIH), NCI ZIABC011700 (to T.S.U.), and ZIABC010888 (to R.Y.). Additional U.S. federal support came from the NCI, UM1CA154967 (to M.A.C.), NIH contracts HHSN261200800001E and 75N91019D00024 (to J.D.L.), the National Institutes of Health Intramural Program, and the National Institutes for Allergy and Infectious Diseases UM1AI126611 [Delaney AIDS Research Enterprise (DARE) Collaboratory to S.G.D., S.R.L., R.S., and N.C.]. Additional study funding was obtained from the National Health and Medical Research Council (NHMRC) of Australia including an NHMRC program grant (to S.R.L.) and practitioner fellowship (to S.R.L.). Merck & Co. Inc., Kenilworth, NJ, USA provided funding to the NCI Cancer Therapy Evaluation Program and CITN in support of clinical trial NCT02595866.