Overview

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