Status:
UNKNOWN
Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Acquired Immune Deficiency Syndrome Virus
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
NA
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 b...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00974285
Start Date
September 1 2009
End Date
December 1 2010
Last Update
October 29 2009
Active Locations (1)
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1
Jie, WANG
Beijing, Beijing Municipality, China, 100053