HIVNCT01328288
Progress Pediatric Study
An observational study of HIV and Depression, run by The HIV Netherlands Australia Thailand Research Collaboration at 5 sites in Thailand.
Trial summary
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- HIV, Depression
- What is being tested?
- standard ART according to the Thai Ministry of Public Health national guidelines
- How many people
- 840 participants
- Where
- 5 sitesThailand
- Study dates
- Jan 2009to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- age < 18 years old
- Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR)
- Signed consent form
Who cannot join
- Hospitalization
- Emergency case
- Incomplete Medical Record
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Thailand5 sites
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok
Chiangrai Prachanukroh Hospital
Chiang Rai, Changwat Chiang Rai
Bamrasnaradura infectious disease institute
Nonthaburi, Changwat Nonthaburi, 11000
Sanpatong Hospital
Sanpathong, Chiang Mai
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Depression
- Being tested
- standard ART according to the Thai Ministry of Public Health national guidelines
- Keywords
- HIV related adverse events, Immunological failure, virological failure, quality of life, depression, genotypic resistance
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard ART according to the Thai Ministry of Public Health national guidelinesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | long-term follow-up of HIV-infected children Receives: Drug: standard ART according to the Thai Ministry of Public Health national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV related adverse events
time to HIV related adverse events
Measured: 1 year
Secondary outcomes (5)
Immunological failure
time to immunological failure
Measured: 1 year
virological failure
time to virological failure
Measured: 1 year
quality of life
time to change of quality of life
Measured: 1 year
depression
when patient develops depression
Measured: 1 year
genotypic resistance
time to genotypic resistance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJan 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Bamrasnaradura Infectious Diseases Institute, Mahidol University, Chiangrai Prachanukroh Hospital, Sanpatong Hospital
- Responsible party
- Sponsor
- Investigators
- Wisit Prasithsirikul, MD, Principal investigator, Bamrasnaradura infectious disease instituteRawiwan Hansudewechakul, MD, Principal investigator, Chiangrai Prachanukroh HospitalWirat Klinbuayam, MD, Principal investigator, Sanpatong HospitalJintanat Ananworanich, MD, PhD, Principal investigator, Thai Red Cross AIDS Research CentreKulkanya Chokephaibulkit, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328288
- Sponsor's protocol ID
- HIV-NAT 154
- Status last verified
- Feb 2016
- First submitted
- 2 Mar 2011
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25478649
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai Pediatric HIV Disease Progression: An Observational Database
- ClinicalTrials.gov ID
- NCT01328288
- Acronym / sponsor ID
- HIV-NAT 154
- Conditions
- HIV, Depression
- Keywords
- HIV related adverse events, Immunological failure, virological failure, quality of life, depression, genotypic resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Bamrasnaradura Infectious Diseases Institute, Mahidol University, Chiangrai Prachanukroh Hospital, Sanpatong Hospital
- Study start
- Jan 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: standard ART according to the Thai Ministry of Public Health national guidelineslong-term follow-up of HIV-infected children |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- age < 18 years old
- Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR)
- Signed consent form
Key exclusion criteria (3 listed)
- Hospitalization
- Emergency case
- Incomplete Medical Record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard ART according to the Thai Ministry of Public Health national guidelinesPatients 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. | Drug | 1 |
Primary outcome
HIV related adverse events
Time frame: 1 year
time to HIV related adverse events
5 secondary outcomes
Immunological failure
Time frame: 1 year
virological failure
Time frame: 1 year
quality of life
Time frame: 1 year
depression
Time frame: 1 year
genotypic resistance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Results publication: PubMed 25478649Bunupuradah 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.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wisit Prasithsirikul, MD principal investigator
Bamrasnaradura infectious disease institute
Rawiwan Hansudewechakul, MD principal investigator
Chiangrai Prachanukroh Hospital
Wirat Klinbuayam, MD principal investigator
Sanpatong Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Depression, run by The HIV Netherlands Australia Thailand Research Collaboration at 5 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV related adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01328288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.