Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT00974285
First received: September 9, 2009
Last updated: October 28, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acquired Immune Deficiency Syndrome Virus HIV Infections |
Drug: Fuzheng 1 Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Primary Outcome Measures:
- Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immune reconstitution efficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Viral load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clinical symptoms and signs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- KPS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Economic evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974285
Contacts
| Contact: Jie LIU | 8610-88001381 | dr.liujie@163.com |
Locations
| China, Beijing | |
| Jie, WANG | Recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Jie LIU, MD 8610-88001381 dr.liujie@163.com | |
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 |
More Information
No publications provided
| Responsible Party: | WANG, Jie/Professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00974285 History of Changes |
| Other Study ID Numbers: | 09.07.16-3 |
| Study First Received: | September 9, 2009 |
| Last Updated: | October 28, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
|
AIDS complementary therapies |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013