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

Primary Purpose

Acquired Immune Deficiency Syndrome Virus, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fuzheng 1
Placebo
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immune Deficiency Syndrome Virus focused on measuring AIDS, complementary therapies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jie, WANGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fuzheng 1

Placebo

Arm Description

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.

Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Outcomes

Primary Outcome Measures

Peripheral blood CD3+ CD4+ counts

Secondary Outcome Measures

Immune reconstitution efficiency
Viral load
Clinical symptoms and signs
KPS score
Quality of life score
Safety evaluation
Economic evaluation

Full Information

First Posted
September 9, 2009
Last Updated
October 28, 2009
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00974285
Brief Title
Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Official Title
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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. 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. Through the clinical trials, we are going to evaluate the efficacy and safety of Immunity 1 (Fuzheng 1) on immune reconstitution of HIV patients in WHOⅠ、II period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immune Deficiency Syndrome Virus, HIV Infections
Keywords
AIDS, complementary therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fuzheng 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Intervention Type
Drug
Intervention Name(s)
Fuzheng 1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Primary Outcome Measure Information:
Title
Peripheral blood CD3+ CD4+ counts
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Immune reconstitution efficiency
Time Frame
6 months
Title
Viral load
Time Frame
6 months
Title
Clinical symptoms and signs
Time Frame
6 months
Title
KPS score
Time Frame
6 months
Title
Quality of life score
Time Frame
6 months
Title
Safety evaluation
Time Frame
6 months
Title
Economic evaluation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie LIU
Phone
8610-88001381
Email
dr.liujie@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie WANG, MD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Jie, WANG
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie LIU, MD
Phone
8610-88001381
Email
dr.liujie@163.com

12. IPD Sharing Statement

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

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