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Progress Pediatric Study

This study has been completed.
Sponsor:
Collaborators:
Bamrasnaradura Infectious Diseases Institute
Mahidol University
Chiangrai Prachanukroh Hospital
Sanpatong Hospital
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01328288
First received: March 2, 2011
Last updated: February 19, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.

Condition Intervention
HIV
Depression
Drug: standard ART according to the Thai Ministry of Public Health national guidelines

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Pediatric HIV Disease Progression: An Observational Database

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • HIV related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to HIV related adverse events


Secondary Outcome Measures:
  • Immunological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to immunological failure

  • virological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to virological failure

  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    time to change of quality of life

  • depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    when patient develops depression

  • genotypic resistance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to genotypic resistance


Biospecimen Retention:   Samples With DNA
serum

Enrollment: 840
Study Start Date: January 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328288

Locations
Thailand
Sanpatong Hospital
Sanpathong, Chiang Mai, Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Bamrasnaradura infectious disease institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
Mahidol University
Chiangrai Prachanukroh Hospital
Sanpatong Hospital
Investigators
Principal Investigator: Wisit Prasithsirikul, MD Bamrasnaradura infectious disease institute
Principal Investigator: Rawiwan Hansudewechakul, MD Chiangrai Prachanukroh Hospital
Principal Investigator: Wirat Klinbuayam, MD Sanpatong Hospital
Principal Investigator: Jintanat Ananworanich, MD, PhD HIV-NAT, Thai Red Cross - AIDS Research Centre
Principal Investigator: Kulkanya Chokephaibulkit, MD Mahidol University
  More Information

Additional Information:
Publications:
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01328288     History of Changes
Other Study ID Numbers: HIV-NAT 154 
Study First Received: March 2, 2011
Last Updated: February 19, 2016
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV related adverse events
Immunological failure
virological failure
quality of life
depression
genotypic resistance

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on December 09, 2016