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

NCT00974519 | Unknown

• 1 other identifier: 09.07.16-2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acquired Immune Deficiency Syndrome Virus; HIV Infections

Keywords

ADIS; complementary therapies

Outcome Measures

Primary Outcomes (1)

• Peripheral blood CD3+ CD4+ counts

  6 months

Secondary Outcomes (8)

• Immune reconstitution efficiency

  6 months

• Viral load

  6 months

• Clinical symptoms and signs

  6 months

• KPS score

  6 months

• Quality of life score

  6 months

Study Arms (3)

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

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

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

Interventions

Fuzheng 3 DRUG

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 3

Fuzheng 1 DRUG

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.

Fuzheng 1

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Jie, WANG

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jie WANG, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

Jie Liu, MD

CONTACT

8610-88001381; dr.liujie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 29, 2009

Record last verified: 2009-09

Locations

CN (1)