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No adverse safety or virological changes two years following vorinostat in HIV-infected individuals on antiretroviral therapy.

No adverse safety or virological changes two years following vorinostat in HIV-infected individuals on antiretroviral therapy.
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Mota TM, Rasmussen TA, Rhodes A, Tennakoon S, Dantanarayana A, Wightman F, Hagenauer M, Roney J, Spelman T, Purcell DF, McMahon J, Hoy JF, Prince HM, Elliott JH, Lewin SR,


Mota TM, Rasmussen TA, Rhodes A, Tennakoon S, Dantanarayana A, Wightman F, Hagenauer M, Roney J, Spelman T, Purcell DF, McMahon J, Hoy JF, Prince HM, Elliott JH, Lewin SR, (click to view)

Mota TM, Rasmussen TA, Rhodes A, Tennakoon S, Dantanarayana A, Wightman F, Hagenauer M, Roney J, Spelman T, Purcell DF, McMahon J, Hoy JF, Prince HM, Elliott JH, Lewin SR,

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AIDS (London, England) 2017 03 15() doi 10.1097/QAD.0000000000001442

Abstract
OBJECTIVE
To determine the long term effects of vorinostat on safety and virological parameters in HIV-infected individuals on suppressive antiretroviral therapy (ART).

DESIGN
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 post enrolment in the initial clinical trial.

METHODS
Cell-associated unspliced (CA-US) 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 Wilcoxon matched pair signed-rank test and Generalised Estimating Equations for trend modelling.

RESULTS
We recorded a total of 31 adverse events (26 grade 1 and 5 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, CA-US HIV RNA, plasma RNA, or CD4 and CD8+ T cells at 6, 12, 18 or 24 months.

CONCLUSIONS
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.

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