EUCTR2012-000240-94-DK进行中（未招募）不适用
The Safety and Efficacy of The Histone Deacetylase Inhibitor Panobinostat for Purging HIV-1 from The Latent Reservoir (CLEAR) Study - CLEAR
Aarhus University Hospital0 个研究点开始时间: 2012年4月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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)
- •oHepatic transaminases (AST or ALT) =3 x upper limit of normal (ULN)
- •oSerum total bilirubin =1.5 ULN
- •oSerum creatinine levels =1.5 x ULN, or calculated creatinine clearance =60 ml/min
- •oPlatelet count =100 x109/L
- •oAbsolute neutrophil count =1.5x109/L
- •oSerum potassium, magnesium, phosphorus outside normal limits
- •oTotal 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
- •Has 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
研究者
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