Progress Pediatric Study
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
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: February 19, 2016
Last verified: February 2016
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Purpose
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.
| Condition | Intervention |
|---|---|
|
HIV Depression |
Drug: standard ART according to the Thai Ministry of Public Health national guidelines |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Thai Pediatric HIV Disease Progression: An Observational Database |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- HIV related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]time to HIV related adverse events
Secondary Outcome Measures:
- 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
Biospecimen Retention: Samples With DNA
serum
| Enrollment: | 840 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2015 |
| Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
long-term follow-up of HIV-infected children
|
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.
|
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328288
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328288
Locations
| Thailand | |
| Sanpatong Hospital | |
| Sanpathong, Chiang Mai, Thailand | |
| HIV-NAT, Thai Red Cross AIDS Research Centre | |
| Bangkok, Thailand, 10330 | |
| Faculty of Medicine Siriraj Hospital, Mahidol University | |
| Bangkok, Thailand | |
| Chiangrai Prachanukroh Hospital | |
| Chiang Rai, Thailand | |
| Bamrasnaradura infectious disease institute | |
| Nonthaburi, Thailand, 11000 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
Mahidol University
Chiangrai Prachanukroh Hospital
Sanpatong Hospital
Investigators
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT01328288 History of Changes |
| Other Study ID Numbers: | HIV-NAT 154 |
| Study First Received: | March 2, 2011 |
| Last Updated: | February 19, 2016 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
HIV related adverse events Immunological failure virological failure |
quality of life depression genotypic resistance |
Additional relevant MeSH terms:
|
Depression Behavioral Symptoms |
ClinicalTrials.gov processed this record on September 26, 2016