title: No adverse safety or virological changes 2 years following vorinostat in HIV-infected individuals on antiretroviral therapy.
abstract: To determine the long-term effects of vorinostat on safety and virological parameters in HIV-infected individuals on suppressive antiretroviral therapy (ART).
  
  
  
  Prospective longitudinal observational extended follow-up of 20 HIV-infected individuals on ART previously enrolled in a clinical trial of daily vorinostat 400 mg for 14 days. Extended follow-up included visits at 6, 12, 18 and 24 months postenrolment in the initial clinical trial.
  
  
  
  Cell-associated unspliced HIV RNA, total HIV DNA and plasma HIV RNA were quantified by PCR, and CD4 and CD8 T cells quantified by flow cytometry. Changes over time in each parameter were assessed using the Wilcoxon matched pair signed-rank test and generalized estimating equations for trend modelling.
  
  
  
  We recorded a total of 31 adverse events (26 grade 1 and five grade 2) in all study participants (n = 20). There were no significant changes in the number of CD4 or CD8 T cells or plasma HIV RNA over time. In 12 participants for whom baseline samples were available, there were no significant changes in total HIV DNA, cell-associated unspliced HIV RNA, plasma RNA or CD4 and CD8 T cells at 6, 12, 18 or 24 months.
  
  
  
  Extended follow-up for 24 months did not reveal any long-term toxicity or changes in markers of HIV persistence or transcription in participants on ART who had received 14 days of vorinostat.
authors.affiliation: aThe Peter Doherty Institute for Infection and Immunity, The University of Melbourne and Royal Melbourne Hospital bDepartment of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, The University of Melbourne cCentre for Population Health, Burnet Institute, Melbourne, Victoria, Australia dDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark eDepartment of Infectious Diseases, Alfred Health and Monash University fPeter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: Talia M
authors.initials: TM
authors.lastname: Mota
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Rasmussen
authors.forename: Ajantha
authors.initials: A
authors.lastname: Rhodes
authors.forename: Surekha
authors.initials: S
authors.lastname: Tennakoon
authors.forename: Ashanti
authors.initials: A
authors.lastname: Dantanarayana
authors.forename: Fiona
authors.initials: F
authors.lastname: Wightman
authors.forename: Michelle
authors.initials: M
authors.lastname: Hagenauer
authors.forename: Janine
authors.initials: J
authors.lastname: Roney
authors.forename: Tim
authors.initials: T
authors.lastname: Spelman
authors.forename: Damian F J
authors.initials: DFJ
authors.lastname: Purcell
authors.forename: James
authors.initials: J
authors.lastname: McMahon
authors.forename: Jennifer F
authors.initials: JF
authors.lastname: Hoy
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Julian H
authors.initials: JH
authors.lastname: Elliott
authors.forename: Sharon R
authors.initials: SR
authors.lastname: Lewin
mesh_terms: D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D056572:Histone Deacetylase Inhibitors; D006801:Humans; D006877:Hydroxamic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D008137:Longitudinal Studies; D009369:Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D019562:Viral Load; D000077337:Vorinostat
chemical_list: D044966:Anti-Retroviral Agents; D000970:Antineoplastic Agents; D056572:Histone Deacetylase Inhibitors; D006877:Hydroxamic Acids; D000077337:Vorinostat