ClinicalTrials.gg
Sign In
Status unknownNCT00974285Updated Oct 29, 2009

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

An interventional study of Fuzheng 1 and Placebo in Acquired Immune Deficiency Syndrome Virus and HIV Infections, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-10-29.

Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acquired Immune Deficiency Syndrome Virus
  • HIV Infections

Keywords

  • AIDS
  • complementary therapies
03

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's planned enrollment of 60 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 136 studies on the registry; 37 are open to participants now.

Browse Guang'anmen Hospital of China Academy of Chinese Medical Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Fuzheng 1

    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 comparator
    Placebo

    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

  • DrugFuzheng 1

    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.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Peripheral blood CD3+ CD4+ counts

    Time frame: 6 months

Secondary outcomes

  1. Immune reconstitution efficiency

    Time frame: 6 months

  2. Viral load

    Time frame: 6 months

  3. Clinical symptoms and signs

    Time frame: 6 months

  4. KPS score

    Time frame: 6 months

  5. Quality of life score

    Time frame: 6 months

  6. Safety evaluation

    Time frame: 6 months

  7. Economic evaluation

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Jie, WANG
    Beijing, Beijing Municipality 100053, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00974285
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted
Sep 10, 2009
Start date
Sep 2009
Primary completion
Jun 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Oct 29, 2009

Study contacts

Jie LIU
Contact
dr.liujie@163.com
8610-88001381
Jie WANG, MD
study chair · Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acquired Immunodeficiency Syndrome →

Other studies from this sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences →

Start the discussion