Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients

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

Summary

The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention measures.

• 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 counts> 350 cells / ul and <550 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:

• Patients in WHO clinical stage Ⅲ, Ⅳ

• 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 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 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