The Effect of Combination of Traditional Chinese Medicine (TCM) and Highly Active Antiretroviral Therapy (HAART) on Immune Reconstitution of HIV/AIDS Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was Recruiting
Recruitment status was Recruiting
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:
NCT00974519
First received: September 9, 2009
Last updated: October 28, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acquired Immune Deficiency Syndrome Virus HIV Infections |
Drug: Fuzheng 3 Drug: Fuzheng 1 Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Combination of TCM and HAART on Immune Reconstitution of HIV/AIDS Patients |
Resource links provided by NLM:
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 effect 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: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fuzheng 3
Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
|
Drug: Fuzheng 3
Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. Immunity 1 (Fuzheng 1) simulation agent, 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.
|
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. Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. |
|
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.
|
Drug: Placebo
Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. |
Detailed Description:
- Meng Kun found that Joint application of Chuankezhi can enhance the number of CD4 cells and reduce side-effects of HAART compared with HAART alone. in order to verify the long-term efficacy of combination therapy, they carried out an clinical observations of three cases of patients who received combination therapy for over a period of 3 years, through the observation of three cases of patients, they found that CD3+CD4+T lymphocyte count were significantly increased and HIV-RNA viral load were below 50copies for long-term, and without the occurrence of drug resistance. And the patient's symptoms and signs have also been significantly improved.
- Duan Cheng Yu analyses 334 cases of AIDS patients' clinical symptoms, signs and Karnofsky score, and CD3+CD4+ T lymphocyte count before and after treatment. The patients all take "kang ai bao sheng" capsules for 3 months. The results showed that 334 cases of patients receiving traditional Chinese and western medicine treatment shows improvement in symptoms and signs, increase in CD3+CD4+ T lymphocyte count. They proposed that combination of traditional Chinese and western medicine can improve symptoms, enhance immunity function and improve the quality of life of AIDS patients.
- In order to observe the effect of combination of TCM and HAART on HIV/AIDS patients, ZHANG Ai-min divided 63 cases of AIDS into 3 groups. 20 cases received TCM treatment and 22 cases received combination of TCM and HAART, 21 cases received western medicine. The patients' symptoms, signs, Karnofsky score points, CD3+CD4+T lymphocyte counts and HIV-RNA viral load were recorded and compare the difference between the 3 groups. The results showed that combination treatment can more effectively improve the immune function of HIV/AIDS patients, reduce HIV-RNA viral load, and improve the patients' symptoms, signs and the quality of life.
- 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 combination of TCM and HAART on immune reconstitution of HIV/AIDS patients.
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
- CD 4 count ≤ 350 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:
- 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 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 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: NCT00974519
Contacts
| Contact: Jie Liu, MD | 8610-88001381 | dr.liujie@163.com |
Locations
| China, Beijing | |
| Jie, WANG | 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: | WANG, Jie/Professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00974519 History of Changes |
| Other Study ID Numbers: | 09.07.16-2 |
| Study First Received: | September 9, 2009 |
| Last Updated: | October 28, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
|
ADIS complementary therapies |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013