Ignite Creation Date:
2024-05-05 @ 9:50 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00974285
Status:
UNKNOWN
Last Update Posted:
2009-10-29
First Post:
2009-09-09
Brief Title:
Clinical Trials on the Effect of Immunity 1 Fuzheng 1 on Immune Reconstitution of HIV Patients
Sponsor:
Guanganmen Hospital of China Academy of Chinese Medical Sciences
Organization:
Guanganmen Hospital of China Academy of Chinese Medical Sciences
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50100cellsulyear When the CD4 T lymphocyte count dropped below 350cellsul and viral load increased to 105 in AIDS patients HAART will be carried out But CD4 T lymphocyte was 350550 cellsul 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 50100cellsulyear When the CD4 T lymphocyte count dropped below 350cellsul and viral load increased to 105 in AIDS patients HAART will be carried out But CD4 T lymphocyte was 350550 cellsul 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 CD3CD4T 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 WHOⅠII period
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 CD3CD4T 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 WHOⅠII period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None