Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)

October 28, 2009 updated by: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Research on Effect of TCM on Immune Reconstitution of HIV/AIDS Patients After HAART

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 Comparator: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral blood CD3+ CD4+ counts
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Viral load
Time Frame: 6 months
6 months
Immune reconstitution efficiency
Time Frame: 6 months
6 months
Clinical symptoms and signs
Time Frame: 6 months
6 months
KPS score
Time Frame: 6 months
6 months
Quality of life score
Time Frame: 6 months
6 months
Side effects of HAART
Time Frame: 6 months
6 months
Safety evaluation
Time Frame: 6 months
6 months
Economic evaluation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.07.16-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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