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

Not Applicable

• Conditions: Acquired Immune Deficiency Syndrome Virus; HIV Infections
• Interventions: Drug: Fuzheng 1; Drug: Placebo

• Registration Number: NCT00974285
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 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.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Last Update Submitted: 2009-10-28
• Last Update Posted: 2009-10-29
• Primary Completion: 2010-06
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 Ⅲ, Ⅳ
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuzheng 1	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	Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Primary Outcome Measures

Name	Time	Method
Peripheral blood CD3+ CD4+ counts	6 months

Secondary Outcome Measures

Name	Time	Method
Immune reconstitution efficiency	6 months
Viral load	6 months
Clinical symptoms and signs	6 months
KPS score	6 months
Quality of life score	6 months
Safety evaluation	6 months
Economic evaluation	6 months

Trial Locations

Locations (1)

Jie, WANG; 🇨🇳 Beijing, Beijing, China