NCT01210924

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2018

Status Verified

November 1, 2013

Enrollment Period

5.7 years

First QC Date

September 27, 2010

Last Update Submit

March 28, 2018

Conditions

Acquired Immunodeficiency Syndrome

Keywords

childrenAcquired Immunodeficiency Syndromeantiretroviral therapyChinaMortality

Outcome Measures

Primary Outcomes (1)

  • The immunology and virologic outcomes

    2016

Study Arms (1)

Pediatric ART patients

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric HIV-infected patients receiving triple antiretroviral drugs

You may qualify if:

  • clinical diagnosis of HIV infection
  • receiving triple antiretroviral drugs

You may not qualify if:

  • clinical status not stable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 102206, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plamsa, PMBC, whole blood

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fujie Zhang, MD

    National Center for AIDS/STD control and prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 29, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2018

Record last verified: 2013-11

Locations

CN(1)