Progress Pediatric Study
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![](https://webarchive.library.unt.edu/web/20130309094317im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.
Condition | Intervention |
---|---|
Acquired Immunodeficiency Syndrome 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 |
- HIV related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]time to HIV related adverse events
- 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
Estimated Enrollment: | 840 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2015 |
Estimated 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.
![](https://webarchive.library.unt.edu/web/20130309094317im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | 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
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
![](https://webarchive.library.unt.edu/web/20130309094317im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Wisit Prasithsirikul, MD | 6625903408 | drwisit_p@yahoo.com |
Contact: Kulkanya Chokephaibulkit, MD | 66816110371 | sikch@mahidol.ac.th |
Thailand | |
Sanpatong Hospital | Recruiting |
Sanpathong, Chiang Mai, Thailand | |
Contact: Wirat Klinbuayam, MD | |
Principal Investigator: Wirat Klinbuayam, MD | |
Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting |
Bangkok, Thailand | |
Contact: Kulkanya Chokephaibulkit, MD sikch@mahidol.ac.th | |
Principal Investigator: Kulkanya Chokephaibulkit, MD | |
HIV-NAT, Thai Red Cross AIDS Research Center | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Jintanat Ananworanich, MD, PhD 662-652-3040 ext 280 jintanat.a@hivnat.org | |
Principal Investigator: Jintanat Ananworanich, MD, PhD | |
Chiangrai Prachanukroh Hospital | Recruiting |
Chiang Rai, Thailand | |
Contact: Rawiwan Hansudewechakul, MD | |
Principal Investigator: Rawiwan Hansudewechakul, MD | |
Bamrasnaradura infectious disease institute | Recruiting |
Nonthaburi, Thailand, 11000 | |
Contact: Wisit Prasithsirikul, MD | |
Principal Investigator: Wisit Prasithsirikul, MD |
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 Center |
Principal Investigator: | Kulkanya Chokephaibulkit, MD | Mahidol University |
![](https://webarchive.library.unt.edu/web/20130309094317im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Wisit Prasithsirikul, Bamrasnaradura Infectious Disease Institute |
ClinicalTrials.gov Identifier: | NCT01328288 History of Changes |
Other Study ID Numbers: | HIV-NAT 154 |
Study First Received: | March 2, 2011 |
Last Updated: | April 1, 2011 |
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:
Acquired Immunodeficiency Syndrome HIV Infections Depression Depressive Disorder Immunologic Deficiency Syndromes Disease Progression Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Behavioral Symptoms Mood Disorders Mental Disorders Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on March 07, 2013