Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
- Conditions
- Acquired Immune Deficiency Syndrome VirusHIV Infections
- Interventions
- Drug: Fuzheng 1Drug: Placebo
- Registration Number
- NCT00974285
- Brief Summary
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.
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fuzheng 1 Fuzheng 1 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. Placebo Placebo Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
- Primary Outcome Measures
Name Time Method Peripheral blood CD3+ CD4+ counts 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Jie, WANG
🇨🇳Beijing, Beijing, China