Clinical trial NCT01328288: Progress Pediatric Study
Official title: The Thai Pediatric HIV Disease Progression: An Observational Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Depression
Keywords: HIV related adverse events
Immunological failure
virological failure
quality of life
depression
genotypic resistance
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Bamrasnaradura Infectious Diseases Institute
name: Mahidol University
name: Chiangrai Prachanukroh Hospital
name: Sanpatong Hospital
First posted: 2011-04-04
Enrollment: 840
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: HIV related adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Immunological failure
timeFrame: 1 year
measure: virological failure
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
measure: depression
timeFrame: 1 year
measure: genotypic resistance
timeFrame: 1 year
Other outcomes:
Locations:
city: Sanpathong
country: Thailand
facility: Sanpatong Hospital
state: Chiang Mai
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross AIDS Research Centre
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura infectious disease institute
Study officials:
affiliation: Bamrasnaradura infectious disease institute
name: Wisit Prasithsirikul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiangrai Prachanukroh Hospital
name: Rawiwan Hansudewechakul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanpatong Hospital
name: Wirat Klinbuayam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre
name: Jintanat Ananworanich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Kulkanya Chokephaibulkit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 children and adolescents. Pediatr Infect Dis J. 2015 Mar;34(3):e58-62. doi: 10.1097/INF.0000000000000584.