Status:
UNKNOWN
Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Acquired Immune Deficiency Syndrome Virus
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reco...
Detailed Description
* There is no record of AIDS in Chinese medicine, modern clinicians hold that AIDS is linked to TCM theory according to its pathogenesis, character of onset and clinical manifestations. As early as mo...
Eligibility Criteria
Inclusion
- HIV antibody-positive, confirmed by Western Blot test
- HIV antibody-positive, confirmed by Western Blot test
- HAART ≥ 12 months
- CD 4 count increased by \<100 cells / ul
- HIV RNA \<50 c / ml (bDNA);
- Age ≥ 18 years old and ≤ 70 years old
- Voluntary participated in this study, signed informed consent form, and could be followed-up
Exclusion
- 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 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00974454
Start Date
September 1 2009
End Date
December 1 2010
Last Update
October 29 2009
Active Locations (1)
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1
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053