Progress Pediatric Study

Depression Clinical Trial

Official title:

The Thai Pediatric HIV Disease Progression: An Observational Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328288
• Other study ID #: HIV-NAT 154
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: February 19, 2016
• Start date: January 2009
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• HIV

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok
Thailand	HIV-NAT, Thai Red Cross AIDS Research Centre	Bangkok
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai
Thailand	Bamrasnaradura infectious disease institute	Nonthaburi
Thailand	Sanpatong Hospital	Sanpathong	Chiang Mai

Sponsors (5)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Bamrasnaradura Infectious Diseases Institute, Chiangrai Prachanukroh Hospital, Mahidol University, Sanpatong Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Bunupuradah T, Sricharoenchai S, Hansudewechakul R, Klinbuayaem V, Teeraananchai S, Wittawatmongkol O, Akarathum N, Prasithsirikul W, Ananworanich J; Pediatric PROGRESS Study Team. Risk of first-line antiretroviral therapy failure in HIV-infected Thai chi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV related adverse events	time to HIV related adverse events	1 year	Yes
Secondary	Immunological failure	time to immunological failure	1 year	Yes
Secondary	virological failure	time to virological failure	1 year	Yes
Secondary	quality of life	time to change of quality of life	1 year	No
Secondary	depression	when patient develops depression	1 year	No
Secondary	genotypic resistance	time to genotypic resistance	1 year	Yes

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)