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

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

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