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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acquired Immune Deficiency Syndrome Virus, HIV Infections

Intervention / Treatment
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* Drug: Fuzheng 3
* Drug: Fuzheng 1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fuzheng 3<br>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<br>* 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.<br>|
| Active Comparator: Fuzheng 1<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood CD3+ CD4+ counts |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADIS, complementary therapies