Panobinostat, a histone deacetylase inhibitor, for latent-virus reactivation in HIV-infected patients on suppressive antiretroviral therapy: a phase 1/2, single group, clinical trial
Thomas A Rasmussen, Martin Tolstrup, Christel R Brinkmann, Rikke Olesen, Christian Erikstrup, Ajantha Solomon, Anni Winckelmann, Sarah Palmer, Charles Dinarello, Maria Buzon, Mathias Lichterfeld, Sharon R Lewin, Lars Ostergaard, Ole S Sogaard
LANCET HIV | ELSEVIER INC | Published : 2014
BACKGROUND: Activating the expression of latent virus is an approach that might form part of an HIV cure. We assessed the ability of the histone deacetylase inhibitor panobinostat to disrupt HIV-1 latency and the safety of this strategy. METHODS: In this phase 1/2 clinical trial, we included aviraemic adults with HIV treated at Aarhus University Hospital, Denmark. Participants received oral panobinostat (20 mg) three times per week every other week for 8 weeks while maintaining combination antiretroviral therapy. The primary outcome was change from baseline of cell-associated unspliced HIV RNA. Secondary endpoints were safety, plasma HIV RNA, total and integrated HIV DNA, infectious units pe..View full abstract
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Awarded by Australian National Health and Medical Research Council
Awarded by Division of AIDS, National Institute of Allergy and Infectious Disease, US National Institutes of Health (Delaney AIDS Research Enterprise)
We thank Carsten Schade Larsen, Alex Laursen, and Merete Storgaard for clinical guidance during the study and Henrik Stovring for biostatistical support. Amy Shaw provided technical support and Paul W Denton provided input to the drafting of the report. The study was primarily funded by The Danish Council For Strategic Research, but also received contributions from The Danish AIDS Foundation, The Augustinus Foundation, Frode V Nyegaard Foundation, SSAC Foundation, Aarhus University, Aarhus University Hospital, and the American Fund for AIDS Research. Novartis supplied panobinostat for use in the study. SRL's contribution was supported by an Australian National Health and Medical Research Council project grant 1009533, an NHMRC Practitioner Fellowship and the Division of AIDS, National Institute of Allergy and Infectious Disease, US National Institutes of Health (Delaney AIDS Research Enterprise; U19AI096109). We wish to express our sincere gratitude to the study patients for their participation in the study.