Progress Pediatric Study

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01328288
First received: March 2, 2011
Last updated: March 26, 2015
Last verified: March 2015

March 2, 2011
March 26, 2015
January 2009
September 2015   (final data collection date for primary outcome measure)
HIV related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
time to HIV related adverse events
Same as current
Complete list of historical versions of study NCT01328288 on ClinicalTrials.gov Archive Site
  • Immunological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to immunological failure
  • virological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to virological failure
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    time to change of quality of life
  • depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    when patient develops depression
  • genotypic resistance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to genotypic resistance
Same as current
Not Provided
Not Provided
 
Progress Pediatric Study
The Thai Pediatric HIV Disease Progression: An Observational Database

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum

Probability Sample

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

  • HIV
  • Depression
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.
1
long-term follow-up of HIV-infected children
Intervention: Drug: standard ART according to the Thai Ministry of Public Health national guidelines
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
840
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01328288
HIV-NAT 154
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • Bamrasnaradura Infectious Diseases Institute
  • Mahidol University
  • Chiangrai Prachanukroh Hospital
  • Sanpatong Hospital
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
The HIV Netherlands Australia Thailand Research Collaboration
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP