NCT03407105已完成1 期
A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年4月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Grade of treatment induced DLTs
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL)
- •CD4 count greater than or equal to 100 cells/mm3
- •Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure
- •Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy
- •No significant organ compromise
排除标准
- •Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening
- •Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine
- •History of autoimmune disease at risk for recurrence
- •Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma
- •Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc
- •Currently undergoing treatment or prophylaxis for tuberculosis infection
- •Chronic active infectious disease (other than HIV)
研究组 & 干预措施
Arm 2
Experimental
Specified dose on specified days
干预措施: MDX-010 (Biological)
结局指标
主要结局
Grade of treatment induced DLTs
时间窗: Up to 141 days
Number of treatment emergent AEs (adverse events)
时间窗: Up to 141 days
Number of treatment induced dose limiting toxicities (DLTs)
时间窗: Up to 141 days
次要结局
- HIV Ribonucleic Acid (RNA) level(Up to 141 days)
- CD4 T cell cytokine responses to Candida antigen(Up to 141 days)
- CD4 T cell cytokine responses to tetanus antigen(Up to 141 days)
- CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens(Up to 141 days)
- CD8 T cell cytokine responses to Candida antigen(Up to 141 days)
- CD8 T cell cytokine responses to tetanus antigen(Up to 141 days)
- Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens(Up to 141 days)
- LPA to Candida antigens(Up to 141 days)
- Maximum plasma concentration observed post-dose (Cmax)(Up to 141 days)
- Time of maximum plasma concentration observed post-dose (Tmax)(Up to 141 days)
- CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens(Up to 141 days)
- LPA to tetanus antigens(Up to 141 days)
- Anti-tetanus toxin antibody level(Up to 141 days)
- Number of CD4 T cells(Up to 141 days)
- Number of CD8 T cells(Up to 141 days)
研究者
研究点 (5)
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