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Progress Pediatric Study

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ClinicalTrials.gov Identifier: NCT01328288
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : February 22, 2016
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

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.

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

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

Study Type : Observational
Actual Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Pediatric HIV Disease Progression: An Observational Database
Study Start Date : January 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. HIV related adverse events [ Time Frame: 1 year ]
    time to HIV related adverse events


Secondary Outcome Measures :
  1. Immunological failure [ Time Frame: 1 year ]
    time to immunological failure

  2. virological failure [ Time Frame: 1 year ]
    time to virological failure

  3. quality of life [ Time Frame: 1 year ]
    time to change of quality of life

  4. depression [ Time Frame: 1 year ]
    when patient develops depression

  5. genotypic resistance [ Time Frame: 1 year ]
    time to genotypic resistance


Biospecimen Retention:   Samples With DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01328288     History of Changes
Other Study ID Numbers: HIV-NAT 154
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

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