NCT00974285Unknown不适用
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peripheral blood CD3+ CD4+ counts
研究概览
简要总结
The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention measures.
详细描述
- The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention measures.
- Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.
- Through the clinical trials, we are going to evaluate the efficacy and safety of Immunity 1 (Fuzheng 1) on immune reconstitution of HIV patients in WHOⅠ、II period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV antibody-positive, confirmed by Western Blot test
- •CD 4 counts> 350 cells / ul and <550 cells / ul
- •Age ≥ 18 years old and ≤ 70 years old
- •Voluntary participated in this study, signed informed consent form, and could be followed-up
排除标准
- •Patients in WHO clinical stage Ⅲ, Ⅳ
- •Participated in clinical trials of other drugs within one month before the experiment
- •Received antiretroviral therapy or are anti-HIV drugs such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and fusion-inhibiting agent (FIs), integrase inhibitors, inhibitors penetration within one month before the experiment
- •Received immunomodulatory treatment within one month before the experiment Liver and kidney dysfunction (AST, ALT, T-BIL ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value)
- •Patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases
- •Persons suffering from autoimmune diseases
- •Cancer patients which need chemotherapy
- •Pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period
- •Hypersensitive people
- •Patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well
研究组 & 干预措施
Fuzheng 1
Active Comparator
Immunity 1 (Fuzheng 1), 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
干预措施: Fuzheng 1 (Drug)
Placebo
Placebo Comparator
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Peripheral blood CD3+ CD4+ counts
时间窗: 6 months
次要结局
- Immune reconstitution efficiency(6 months)
- Viral load(6 months)
- Clinical symptoms and signs(6 months)
- KPS score(6 months)
- Quality of life score(6 months)
- Safety evaluation(6 months)
- Economic evaluation(6 months)
研究者
研究点 (1)
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