A Phase 2 Study To Evaluate The Safety, Tolerability, Virologic And Immunologic Effect Of Single-Dose CP-675,206 In Patients Infected With Human Immunodeficiency Virus

Pfizer0 个研究点开始时间: 2007年7月最近更新: 2015年3月11日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: Pfizer
主要终点: Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is safe and well-tolerated, reduces viral load, and improves immune function in patients infected with HIV.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Single

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•HIV infected man or woman at least 18 years of age who is available for a follow up period of at least 3 months
•Has been on a stable antiretroviral regimen for ≥3 months and willing to remain on current antiretroviral regimen for an additional 3 months or has been off of antiretroviral therapy for at least 8 weeks and willing to remain off of antiretroviral therapy for another 3 months
•Plasma HIV 1 RNA ≥5,000 copies/mL measured by Roche Amplicor HIV 1 Monitor at the screening visit
•CD4 T-cells ≥200 cells/mm3

排除标准

•History of, or significant evidence of risk for, chronic inflammatory or autoimmunedisease (eg, Addison's disease, asthma, celiac disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc)
•History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT-scan only
•Exposure within the previous 3 months to a drug known to have immunomodulatory effects (eg, IL 2)

结局指标

主要结局

Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12

次要结局

Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12

研究者

发起方

Pfizer

申办方类型

Industry

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