Chinese Network of Pediatric Antiretroviral Therapy | NCT01210924

Studies
Chinese Network of Pediatric Antiretroviral Therapy

NCT01210924

Sponsor

National Center for AIDS/STD Control and Prevention, China CDC

Status

Completed

Last Update Posted

Mar 30, 2018Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008ZX10001-007	Other Grant/Funding Number	Chinese Ministory of Health

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 27, 2010

First Submission Date that Met QC Criteria

Sep 27, 2010

First Posted Date

Sep 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Actual

Label	Type	Description	Intervention Names
Pediatric ART patients

Measure	Description	Time Frame
The immunology and virologic outcomes		2016

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of HIV infection
receiving triple antiretroviral drugs

Exclusion Criteria:

clinical status not stable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Pediatric HIV-infected patients receiving triple antiretroviral drugs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fujie Zhang, MD	National Center for AIDS/STD control and prevention	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Center for AIDS/STD Control and Prevention, China Center for Disease Control and Prevention		Beijing		102206	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided