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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Jie, WANG
Beijing, Beijing Municipality, China
RECRUITINGPeripheral blood CD3+ CD4+ counts
Time frame: 6 months
Immune reconstitution efficiency
Time frame: 6 months
Viral load
Time frame: 6 months
Clinical symptoms and signs
Time frame: 6 months
KPS score
Time frame: 6 months
Quality of life score
Time frame: 6 months
Safety evaluation
Time frame: 6 months
Economic evaluation
Time frame: 6 months
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