NCT00974285

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 29, 2009

Status Verified

September 1, 2009

Enrollment Period

9 months

First QC Date

September 9, 2009

Last Update Submit

October 28, 2009

Conditions

Acquired Immune Deficiency Syndrome VirusHIV Infections

Keywords

AIDScomplementary therapies

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood CD3+ CD4+ counts

    6 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

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 1DRUG

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.

Fuzheng 1
PlaceboDRUG

Placebo, 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

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie, WANG

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jie WANG, MD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    STUDY CHAIR

Central Study Contacts

Jie LIU

CONTACT

8610-88001381dr.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)