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

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

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

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 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
Fuzheng 3: Active Comparator 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.
Fuzheng 1: Active Comparator 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: Placebo Comparator 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:	Guang'anmen Hospital of China Academy of Chinese Medical Sciences ( WANG, Jie/Professor )
Study ID Numbers:	09.07.16-2
Study First Received:	September 9, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00974519 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

ADIS
complementary therapies

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