ClinicalTrials.gov
ClinicalTrials.gov Menu

Chinese Network of Pediatric Antiretroviral Therapy (CN-PART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01210924
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms of immunoreconstitution in HIV-infected children using the data and samples from the pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical research network based on the pediatric antiretroviral cohort.

Condition or disease
Acquired Immunodeficiency Syndrome

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chinese Study of Pediatric Antiretroviral Therapy
Study Start Date : April 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Pediatric ART patients


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The immunology and virologic outcomes [ Time Frame: 2016 ]

Biospecimen Retention:   Samples With DNA
plamsa, PMBC, whole blood

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric HIV-infected patients receiving triple antiretroviral drugs
Criteria

Inclusion Criteria:

  • clinical diagnosis of HIV infection
  • receiving triple antiretroviral drugs

Exclusion Criteria:

  • clinical status not stable
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210924


Locations
China
National Center for AIDS/STD Control and Prevention, China Center for Disease Control and Prevention
Beijing, China, 102206
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
Investigators
Principal Investigator: Fujie Zhang, MD National Center for AIDS/STD control and prevention
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier: NCT01210924     History of Changes
Other Study ID Numbers: Pediatric treatment 2010
2008ZX10001-007 ( Other Grant/Funding Number: Chinese Ministory of Health )
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: November 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
children
Acquired Immunodeficiency Syndrome
antiretroviral therapy
China
Mortality

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases