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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00974454
Other study ID # 09.07.16-1
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2009
Last updated October 28, 2009
Start date September 2009
Est. completion date December 2010

Study information

Verified date September 2009
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Jie Liu, MD
Phone 8610-88001381
Email dr.liujie@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Locations

Country Name City State
China Guang'anmen Hospital of China Academy of Chinese Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peripheral blood CD3+ CD4+ counts 6 months No
Secondary Immune reconstitution efficiency 6 months No
Secondary Viral load 6 months No
Secondary Clinical symptoms and signs 6 months No
Secondary KPS score 6 months No
Secondary Quality of life score 6 months No
Secondary Side effects of HAART 6 months No
Secondary Safety evaluation 6 months No
Secondary Economic evaluation 6 months No
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