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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00974285
• Other study ID #: 09.07.16-3
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2009
• Last updated: October 28, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jie LIU
• Phone: 8610-88001381
• Email: dr.liujie[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients in WHO clinical stage ?, ?

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome Virus
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
China	Jie, WANG	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral blood CD3+ CD4+ counts		6 months	No
Secondary	Immune reconstitution efficiency		6 months	No
Secondary	Viral load		6 months	No
Secondary	Clinical symptoms and signs		6 months	No
Secondary	KPS score		6 months	No
Secondary	Quality of life score		6 months	No
Secondary	Safety evaluation		6 months	No
Secondary	Economic evaluation		6 months	No