Progress Pediatric Study

Completed

• Conditions: HIV; Depression
• Interventions: Drug: standard ART according to the Thai Ministry of Public Health national guidelines

• Registration Number: NCT01328288
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	standard ART according to the Thai Ministry of Public Health national guidelines	long-term follow-up of HIV-infected children

Primary Outcome Measures

Name	Time	Method
HIV related adverse events	1 year	time to HIV related adverse events

Secondary Outcome Measures

Name	Time	Method
genotypic resistance	1 year	time to genotypic resistance
depression	1 year	when patient develops depression
Immunological failure	1 year	time to immunological failure
virological failure	1 year	time to virological failure
quality of life	1 year	time to change of quality of life

Trial Locations

Locations (5)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang Rai, Thailand

Sanpatong Hospital; 🇹🇭 Sanpathong, Chiang Mai, Thailand

Bamrasnaradura infectious disease institute; 🇹🇭 Nonthaburi, Thailand

HIV-NAT, Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Thailand