HIV Infections Clinical Trial
Official title:
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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