RPCEC00000213已完成1 期
Evaluation of safety and effect of four doses level of NAcGM3/VSSP formulation as immunopotentiator by subcutaneous route in the treatment of aids patients drug resistant to antiretroviral treatment. - Not applicable
Center of Molecular Immunology (CIM)0 个研究点目标入组 25 人开始时间: 2016年4月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •1. Patients who have signed informed consent.
- •2. AIDS patients with antiretroviral treatment and evidence of multidrug resistance or with CD4 counts below 200 cells / uL for more than 2 consecutive assessments in the last 6 months with controlled viral load (not detectable or with values below the range 1 000 copies).
- •3. Patients aged between 18 and 50 years (including both).
- •4. Patients with overall according to WHO between 0 and 1.
- •5. Patients who have functioning of organs and bone marrow as defined by the following parameters (a) Hematopoietic:
- •Hb>=100 g / L, Leukocytes>= 3 x 109 cells / L, granulocytes>= 1 x 109 cells / L, Platelets >= 150 x 109 cells / L; b) Liver (No more than five times the upper limit of normal (ULN) *), Bilirubin: 17 pmol / L (LSN *), ALAT: 40 U / L (LSN *)
- •ASAT: 40 U / L (LSN *), Alkaline Phosphatase: 279 U / L *, LDH within normal levels: 214 U / L (LSN); c) Renal: Serum creatinine<= 132 pmol / L)
- •6. Life expectancy of 6 months or more.
排除标准
- •1.Patients who have previously received the investigational product .
- •2.Patients receiving other investigational product .
- •3.Patients with known hypersensitivity to any component of the formulation.
- •4.pregnant or lactating patients
- •5.Patients of childbearing age who are not using an appropriate method of contraception ( intrauterine devices, hormonal contraceptives , barrier methods or tubal ligation) . If male (vasectomy , condom use ) during treatment .
- •6.Patients with acute allergic conditions or history of severe allergic reactions.
- •7.Patients suffering from uncontrolled intercurrent illness including, but not limited to : active infections , symptomatic congestive heart failure, unstable angina , cardiac arrhythmia and psychiatric diseases involving the incompetence of the subject.
- •8.Patients with other malignant disease treated correctly in the previous 5 years , except in situ cancer.
- •9.Virus infection Hepatitis B or C.
- •10. Opportunistic at the time of inclusion in the study infection
研究者
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