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Completed

NCT Number: NCT01328288

Progress Pediatric Study

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

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Key information

Conditions

HIV Behavior Behavioral Symptoms Depression

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chiangrai Prachanukroh Hospital, Chiang Rai, Changwat Chiang Rai, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hospitalization
  • Emergency case
  • Incomplete Medical Record

Treatment and study plan

standard ART according to the Thai Ministry of Public Health national guidelines

Drug

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.

Primary outcomes

  1. HIV related adverse events

    Time frame: 1 year

    time to HIV related adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Bamrasnaradura Infectious Diseases Institute
  • Chiangrai Prachanukroh Hospital
  • Mahidol University
  • Sanpatong Hospital

Registry information

Official study title

The Thai Pediatric HIV Disease Progression: An Observational Database

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2011
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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