NCT00974285

Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients

Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immune Deficiency Syndrome Virus
• HIV Infections

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2009-09-10
• Last updated: 2009-10-29

Locations

1 site across 1 country: China