A Pilot Study (Phase I/II) Testing the Immunologic Activity and Safety of AGS-004, an Autologous HIV Immunotherapeutic, in HIV-Infected Adults on HAART
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Immunologic activity of AGS-004 will be as measured by flow cytometry
研究概览
简要总结
To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.
详细描述
Although an HIV infection can induce weak immune responses, current HIV immunotherapy using consensus antigens has not shown consistent clinical activity. The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV antigens and a failure to induce T cell memory. While strong immune responses may be generated to a consensus antigen, those responses do not offer antiviral protection against a patient's individual viral burden. The infecting virus' antigen variability likely prevents the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.
We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date.
This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women age 18 years and over,
- •Documented HIV-1 infection,
- •Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
- •Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
- •CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
- •CD4+ T cell count of ≥350 cells/mm3 obtained within 4 weeks of study entry,
排除标准
- •No co-infection with HBV or HCV,
- •No history of lymph node irradiation or dissection,
- •No prior use of any HIV vaccine,
- •No use of hydroxyurea,
- •No use of systemic corticosteroids or other non-permitted medications,
结局指标
主要结局
Immunologic activity of AGS-004 will be as measured by flow cytometry
时间窗: 18 weeks
次要结局
- To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events(66 weeks)