NCT02191098已完成1 期
Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People on Optimized ART With Undetectable Plasma HIV RNA
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assess the safety and tolerability of ALT-803 in HIV-infected subjects
研究概览
简要总结
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV
详细描述
This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at the maximum tolerated dose (MTD). The primary aim is to investigate the safety and tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after the first infusion and then for 6 hours after each subsequent infusion, provided no unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected adults aged 18 years or over.
- •Stable ART for at least 36 months
- •Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay) ≥ 2 years (a single measurement above the level of detection but < 100-200 copies/ml will be allowed)
- •Screening CD4 count ≥500 cells/mm3
- •Laboratory tests performed within 14 days of study enrollment:
- •WBC ≥ 3000/mm3
- •Platelets ≥ 50,000/mm3 [Patients may be transfused to meet this requirement]
- •Hemoglobin ≥ 8 g/dL (>80g/L) [Patients may be transfused to meet this requirement]
- •Calculated glomerular filtration rate (GFR) >45 mL/min/1.73m2
- •Total bilirubin ≤ 2.0 X upper limit of institutional normal (ULN)
- •AST, ALT, ALP ≤ 2.0 X ULN
- •Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFTs > 50% of predicted if symptomatic or prior known impairment.
- •Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug
- •Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
- •Voluntary written consent
排除标准
- •Active infection other than HIV currently requiring systemic antimicrobial therapy
- •Previously treated on this study or received previous ALT-803
- •Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy
- •Active fungal infection requiring systemic antifungal therapy
- •Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression)
- •Chronic hepatitis B or C
- •Planning or current pregnancy or breastfeeding
- •Intended modification of antiretroviral therapy in the next 24 weeks
- •NYHA (New York Heart Association) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
- •Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening
- •Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
- •History or evidence of uncontrollable CNS disease
- •Prior organ allograft or allogeneic transplantation
- •On-going chronic systemic or regular inhaled corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible)
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Other illness that in the opinion of the investigator would exclude the patient from participating in this study
研究组 & 干预措施
ALT-803
Experimental
ALT-803
干预措施: ALT-803 (Drug)
结局指标
主要结局
Assess the safety and tolerability of ALT-803 in HIV-infected subjects
时间窗: 4 weeks
Safety and tolerability is determined by the incidence of adverse events, size of the inducible reservoir as estimated using the TILDA assay
次要结局
- Assess the impact of ALT-803 on the size of the inducible reservoir,(4 weeks)
研究者
研究点 (1)
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