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

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ClinicalTrials.gov Identifier: NCT00974285
Recruitment Status : Unknown
Verified September 2009 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 10, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

September 9, 2009
September 10, 2009
October 29, 2009
September 2009
June 2010   (Final data collection date for primary outcome measure)
Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00974285 on ClinicalTrials.gov Archive Site
  • Immune reconstitution efficiency [ Time Frame: 6 months ]
  • Viral load [ Time Frame: 6 months ]
  • Clinical symptoms and signs [ Time Frame: 6 months ]
  • KPS score [ Time Frame: 6 months ]
  • Quality of life score [ Time Frame: 6 months ]
  • Safety evaluation [ Time Frame: 6 months ]
  • Economic evaluation [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
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.
  • 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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Acquired Immune Deficiency Syndrome Virus
  • HIV Infections
  • 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.
  • 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.
  • 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.
    Intervention: Drug: Fuzheng 1
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00974285
09.07.16-3
No
Not Provided
Not Provided
WANG, Jie/Professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Not Provided
Study Chair: Jie WANG, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP