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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

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date October 29, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00974285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Official Title  ICMJE Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acquired Immune Deficiency Syndrome Virus
  • HIV Infections
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974285
Other Study ID Numbers  ICMJE 09.07.16-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WANG, Jie/Professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jie WANG, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date September 2009

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