Clinical trial NCT01680094 (phase 1/phase 2, status: completed)
Conditions: hiv infection
ICD codes: Z21
Drugs: panobinostat
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  Age >18 years

          -  HIV-1 plasma RNA <50 copies/ml for at least 2 years with at least 2 viral load
             measures per year. Episodes of a single HIV plasma RNA 50-199 copies/ml will not
             exclude participation if the subsequent HIV plasma RNA was <50 copies/ml

          -  Receiving HAART, defined as at least 2 nucleoside/nucleotide reverse transcriptase
             inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor,
             or a protease inhibitor

          -  CD4+ T-cell count >500/mm3 on minimum 2 occasions in the last 12 months prior to study
             entry

          -  Able to give informed consent

        Exclusion Criteria:

          -  Any significant acute medical illness in the past 8 weeks

          -  Any evidence of an active AIDS-defining opportunistic infection

          -  Current or recent gastrointestinal disease that may impact the absorption of the
             investigational drug

          -  Any gastrointestinal surgery that could impact upon the absorption of the
             investigational drug

          -  Active alcohol or substance use that, in the Investigator's opinion, will prevent
             adequate compliance with study therapy

          -  Patient has the following laboratory values within 3 weeks before starting the
             investigational drug (lab tests may be repeated, as clinically indicated, to obtain
             acceptable values before failure at screening is concluded but supportive therapies
             are not to be administered within the week prior to screening tests for ANC or
             platelet count)

               -  Hepatic transaminases (AST or ALT) ≥3 x upper limit of normal (ULN)

               -  Serum total bilirubin ≥1.5 ULN

               -  Serum creatinine levels ≥1.5 x ULN, or calculated creatinine clearance ≤60 ml/min

               -  Platelet count ≤100 x109/L

               -  Absolute neutrophil count ≤1.5x109/L

               -  Serum potassium, magnesium, phosphorus outside normal limits

               -  Total calcium (corrected for serum albumin) or ionized calcium ≤lower normal
                  limits

          -  Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen
             (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood

          -  A personal history of clinically significant cardiac disease, symptomatic or
             asymptomatic arrhythmias, syncopal episodes, or additional risk factors for Torsades
             de pointes (e.g. heart failure)

          -  History of malignancy or transplantation, including skin cancers or Kaposi sarcoma

          -  History of diabetes mellitus

          -  Use of a protease inhibitor

          -  Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents
             within 28 days prior to study entry

          -  Use of an agent definitely or possibly associated with effects on QT intervals within
             2 weeks of screening

          -  ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula
             from either lead V3 or V4

          -  Known resistance to >2 classes of ART

          -  Known hypersensitivity to the components of panobinostat or its analogues

          -  Current use of sodium valproate or other HDAC inhibitor

          -  Women who are pregnant or breastfeeding, or with a positive pregnancy test during
             screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to
             use an acceptable method of contraception (according to the Danish Medicines Agency
             guidelines) to avoid pregnancy for the entire study period and for at least 4 weeks
             before and 4 weeks after study treatment

          -  Males or females who are unwilling or unable to use barrier contraception during
             sexual intercourse for the entire study period, including at least 4 weeks before, 4
             weeks after study treatment, and when plasma HIV-RNA is detectable using standard
             assays