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Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)
This study is currently recruiting participants.
Verified by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, September 2009
First Received: September 9, 2009   Last Updated: October 28, 2009   History of Changes
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: NCT00974454
  Purpose

Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.


Condition Intervention
Acquired Immune Deficiency Syndrome Virus
HIV Infections
 Drug: Fuzheng 2
Drug: Placebo

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Research on Effect of TCM on Immune Reconstitution of HIV/AIDS Patients After HAART

Resource links provided by NLM:

MedlinePlus related topics: 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 ]
  • Side effects of HAART [ 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: 180
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fuzheng 2: Active Comparator
Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Drug: Fuzheng 2
Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Placebo: Placebo Comparator
Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Drug: Placebo
Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Detailed Description:
  • There is no record of AIDS in Chinese medicine, modern clinicians hold that AIDS is linked to TCM theory according to its pathogenesis, character of onset and clinical manifestations. As early as more than 2000 years ago, there were records of immune function in TCM. 2 TCM books recorded that "keep vital Qi, the evil will not invade the body "and" the invasion of evil is caused by the deficiency of vital Qi. Vital Qi summarizes the normal immune system function. Vital Qi is the basic material and physiological function which can eliminate the evil, regulating yin and yang and protect the body.
  • And this is in accordance with defense, homeostasis and surveillance of immune system in western medicine. The knowledge of immunology has guided medical practice in China for more than two thousand years. In response to a variety of immune diseases, there are various immunotherapy such as Yiqi Fuzheng immunotherapy, reinforce kidney therapy, huoxuehuayu therapy and heat-clearing and detoxifying therapy. Throughout the course of AIDS, the evil (HIV) exists and the vital Qi is turning weak gradually. If we adopted a number of intervention measures to assist the body's Vital Qi, Vital Qi will be strengthened and the evil will be weakened. Therefore, TCM will play an important role in improving immune function.
  • Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.

Researchers screened single Chinese herbs, some extract and the effective components of Chinese medicine and prescriptions. Some study the role of its anti-HIV, some study the role of its regulating immunization function. The former studies have shown that immunization 2 (Fuzheng 2) has wide effect on immune system and it can activate the reticuloendothelial system, macrophage phagocytes and lymphocyte transformation. And it can relieve disorders, imbalance of the immune system caused by HIV infection.

  • In addition, this prescription can inhibit HIV reverse transcription polymerase enzyme and virus-induced syncytium formation, protect virus-infected cells, and inhibit virus replication in HIV-1 infected cells.
  • Through the clinical trials, we will evaluate the effect of immune 2 (Fuzheng 2) on immune reconstitution of adult HIV/AIDS patients who have received HAART.
  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
  • HIV antibody-positive, confirmed by Western Blot test
  • HAART ≥ 12 months
  • CD 4 count increased by <100 cells / ul
  • HIV RNA <50 c / ml (bDNA);
  • Age ≥ 18 years old and ≤ 70 years old
  • Voluntary participated in this study, signed informed consent form, and could be followed-up

Exclusion Criteria:

  • Serious opportunistic infections were not brought under control (Pneumocystis carinii pneumonia, meningitis, esophageal candidiasis, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.) before the experiment
  • Participated in clinical trials of other drugs within one month before the experiment
  • Received immunomodulatory treatment within one month before the experiment
  • WBC <2 × 10 9 / L, N <1.0 × 10 9 / L, Hb <90g / L, PLT <75 × 10 9 / L,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 pancreatitis or active gastric ulcer
  • 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: NCT00974454

Contacts
Contact: Jie Liu, MD 8610-88001381 dr.liujie@163.com

Locations
China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Jie WANG, 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: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ( WANG, Jie/Professor )
Study ID Numbers: 09.07.16-1
Study First Received: September 9, 2009
Last Updated: October 28, 2009
ClinicalTrials.gov Identifier: NCT00974454     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
AIDS
complementary therapies
treatment experienced

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Disease
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
 Virus Diseases
Pathologic Processes
HIV Infections
Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010



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