EUCTR2015-005238-23-DK进行中（未招募）1 期
A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP) - ROADMAP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •1) Adults age 18-65 years with documented HIV-1 infection
- •2) CD4+ T-cell count >500 cells/mm3 at screening
- •3) On ART for a minimum of 18 months and HIV-1 RNA plasma level of < 50 copies/ml by standard assays for at least 12 months (a single viral load measurement > 50 but < 500 copies/ml during this time period is allowable).
- •4) Individuals on protease inhibitor or NNRTI-based regimens must be willing to switch to an integrase-inhibitor-based regimen (raltegravir or dolutegravir) prior to enrollment.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the investigators within the last 6 months
- •2) Pregnancy as determined by a positive urine beta-hCG.
- •3) Participant unwilling to use two reliable contraception methods (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) for the study duration.
- •4) Currently breast-feeding.
- •5) History of resistance to 2 or more classes of antiretroviral medication
- •6) Any medical, psychiatric, social, or occupational condition that, as judged by the investigators, would interfere with the evaluation of study objectives (such as severe alcohol or drug abuse, dementia).
- •7) 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.
- •8) Receipt of an HDAC inhibitor or 3BNC117 in the past 2 years.
- •9) Have a history of AIDS-defining illness within 3 years prior to enrollment.
- •10) History of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
- •11) ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula from either lead V3 or V4.
- •12) Use of Coumadin or Coumadin derivatives
- •13) Laboratory abnormalities in the parameters listed below:
- •13a) Absolute neutrophil count = 1,300
- •13b) Hemoglobin = 10 gm/dL
- •13c) Platelet count = 125,000
- •13d) ALT = 2.0 x ULN
- •13e) AST = 2.0 x ULN
- •13f) Total bilirubin = 2.0 x ULN (for participants on atazanavir, a total bilirubin up to 3 x ULN is allowable)
- •13g) eGFR < 60 mL/min/1.73m2
- •14) Any vaccination within 14 days prior to 3BNC117 administration
- •15) Receipt of any therapeutic HIV vaccine in the past
- •16) Receipt of any monoclonal antibody therapy of any kind in the past 2 years
- •17) Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
研究者
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