Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Study Details
Study Description
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 50100cells/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 350550 cells/ul, there is no intervention measures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte count was reduced gradually at the rate of 50100cells/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 350550 cells/ul, there is no intervention measures.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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: 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.
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| Placebo Comparator: Placebo Placebo, 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.
|
Outcome Measures
Primary Outcome Measures
- Peripheral blood CD3+ CD4+ counts [6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV antibody-positive, confirmed by Western Blot test
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CD 4 counts> 350 cells / ul and <550 cells / ul
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Age ≥ 18 years old and ≤ 70 years old
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Voluntary participated in this study, signed informed consent form, and could be followed-up
Exclusion Criteria:
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Patients in WHO clinical stage Ⅲ, Ⅳ
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Participated in clinical trials of other drugs within one month before the experiment
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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
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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)
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Patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases
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Persons suffering from autoimmune diseases
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Cancer patients which need chemotherapy
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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
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Hypersensitive people
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Patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jie, WANG | Beijing | Beijing | China | 100053 |
Sponsors and Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
- Study Chair: Jie WANG, MD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09.07.16-3