Progress Pediatric Study

February 19, 2016 updated by: The HIV Netherlands Australia Thailand Research Collaboration

The Thai Pediatric HIV Disease Progression: An Observational Database

The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, observational cohort study. HIV-infected children from 5 institutions are followed to assess HIV disease progression: 1. Bamrasnaradura infectious disease institute,2. Faculty of Medicine Siriraj Hospital, Mahidol University, 3. Chiangrai Prachanukroh Hospital, 4. Sanpatong Hospital and 5. HIV-NAT, Thai Red Cross AIDS Research Center.

Study Type

Observational

Enrollment (Actual)

840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre
      • Bangkok, Thailand
        • Faculty of Medicine Siriraj Hospital, Mahidol University
      • Chiang Rai, Thailand
        • Chiangrai Prachanukroh Hospital
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Infectious Disease Institute
    • Chiang Mai
      • Sanpathong, Chiang Mai, Thailand
        • Sanpatong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

long-term follow-up of HIV-infected children from: 1. Bamrasnaradura infectious disease institute, 2. Faculty of Medicine Siriraj Hospital, Mahidol University, 3. Chiangrai Prachanukroh Hospital, Chiang Rai, 4. Sanpatong Hospital, Chiang Mai, and 5. HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok

Description

Inclusion Criteria:

  1. age < 18 years old
  2. Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR)
  3. Signed consent form

Exclusion Criteria:

  1. Hospitalization
  2. Emergency case
  3. Incomplete Medical Record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
long-term follow-up of HIV-infected children
Drug: standard ART according to the Thai Ministry of Public Health national guidelines
Patients may receive any of the standard regimens. These regimens are recommended in the Thai Ministry of Public Health National guidelines for the treatment of HIV in children. Change of treatment will be according to the treating physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV related adverse events
Time Frame: 1 year
time to HIV related adverse events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological failure
Time Frame: 1 year
time to immunological failure
1 year
virological failure
Time Frame: 1 year
time to virological failure
1 year
quality of life
Time Frame: 1 year
time to change of quality of life
1 year
depression
Time Frame: 1 year
when patient develops depression
1 year
genotypic resistance
Time Frame: 1 year
time to genotypic resistance
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Mahidol University
Sanpatong Hospital
Chiangrai Prachanukroh Hospital
Bamrasnaradura Infectious Diseases Institute

Investigators

  • Principal Investigator: Rawiwan Hansudewechakul, MD, Chiangrai Prachanukroh Hospital
  • Principal Investigator: Kulkanya Chokephaibulkit, MD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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