HIVNCT01328275
Progress Adult Study
An observational study of HIV and Depression, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial summary
The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Depression
- What is being tested?
- standard regimens according to the Thai Ministry of Public Health national guidelines
- How many people
- 5,600 participants
- Where
- 3 sitesThailand
- Study dates
- Dec 2007to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients currently receiving ART at Bamrasnaradura Institute, Sanpatong Hospital or HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok.
Who may be able to join
- There is evidence that HIV infection true (blood positive results by ELISA (ELISA) has been confirmed or detected evidence co-infection. HIV in the body by PCR, HIV-RNA PCR).Currently on PI regimens
- Signed consent form
- Age> 18 years
Who cannot join
- Patients who came for treatment in a department other than out patient, such as inpatient or emergency room.
- Patients are not willing to receive treatment on a regular basis in all 3 hospitals as patients normally receive treatment at other hospitals on a regular basis. However, due to urgent events. Need to receive treatment in hospital and three of.
- Patients who have been diagnosed by doctors as a Psychological disorder that can not store the data.
- Patients who have been diagnosed by a medical condition that Alcoholism
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330
Sanpatong Hospital
Chiang Mai, Chiang Mai
Bamrasnaradura infectious disease institute
Nonthaburi, Changwat Nonthaburi, 11000
About this study
Official title: The Thai HIV Disease Progression: An Observational Database
The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult.
Read the detailed description
This is a multicenter, observational prospective cohort study. All HIV-infected patients from Bamrasnaradura Institute, Sanpatong Hospital and HIV-NAT, Thai Red Cross AIDS Research Centre, are followed to assess HIV disease progression.
- Conditions
- HIV, Depression
- Being tested
- standard regimens 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 regimens according to the Thai Ministry of Public Health national guidelinesDrug
Participants 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 patients on ART Receives: Drug: standard regimens 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 until patient has 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
the change of quality of life
time to change of quality of life
Measured: 1 year
depression
time when patient develops depression
Measured: 1 year
genotypic resistance
time to developing 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 startDec 2007
- Primary completionJun 2015
- Study completionJun 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
- 5,600 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, Sanpatong Hospital
- Responsible party
- Sponsor
- Investigators
- Wisit Prasithsirikul, MD, Principal investigator, Bamrasnaradura infectious disease instituteWirat Klinbuayam, MD, Principal investigator, Sanpatong HospitalJintanat Ananworanich, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328275
- Sponsor's protocol ID
- HIV-NAT 153
- Status last verified
- May 2016
- First submitted
- 2 Mar 2011
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pongpirul W, Pongpirul K, Ananworanich J, Klinbuayaem V, Avihingsanon A, Prasithsirikul W. Chronic kidney disease incidence and survival of Thai HIV-infected patients. AIDS. 2018 Jan 28;32(3):393-398. doi: 10.1097/QAD.0000000000001698.
PubMed 29135575
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai HIV Disease Progression: An Observational Database
- ClinicalTrials.gov ID
- NCT01328275
- Acronym / sponsor ID
- HIV-NAT 153
- 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
- 5,600 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Bamrasnaradura Infectious Diseases Institute, Sanpatong Hospital
- Study start
- Dec 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 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 Adult.
Detailed description
This is a multicenter, observational prospective cohort study. All HIV-infected patients from Bamrasnaradura Institute, Sanpatong Hospital and HIV-NAT, Thai Red Cross AIDS Research Centre, are followed to assess HIV disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: standard regimens according to the Thai Ministry of Public Health national guidelineslong-term follow-up of HIV-infected patients on ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients currently receiving ART at Bamrasnaradura Institute, Sanpatong Hospital or HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok.
Key inclusion criteria (3 listed)
- There is evidence that HIV infection true (blood positive results by ELISA (ELISA) has been confirmed or detected evidence co-infection. HIV in the body by PCR, HIV-RNA PCR).Currently on PI regimens
- Signed consent form
- Age> 18 years
Key exclusion criteria (4 listed)
- Patients who came for treatment in a department other than out patient, such as inpatient or emergency room.
- Patients are not willing to receive treatment on a regular basis in all 3 hospitals as patients normally receive treatment at other hospitals on a regular basis. However, due to urgent events. Need to receive treatment in hospital and three of.
- Patients who have been diagnosed by doctors as a Psychological disorder that can not store the data.
- Patients who have been diagnosed by a medical condition that Alcoholism
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 regimens according to the Thai Ministry of Public Health national guidelinesParticipants 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 until patient has HIV related adverse events
5 secondary outcomes
Immunological failure
Time frame: 1 year
virological failure
Time frame: 1 year
the change of 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 11 May 2016.
- Derived from this study: PubMed 29135575Pongpirul W, Pongpirul K, Ananworanich J, Klinbuayaem V, Avihingsanon A, Prasithsirikul W. Chronic kidney disease incidence and survival of Thai HIV-infected patients. AIDS. 2018 Jan 28;32(3):393-398. doi: 10.1097/QAD.0000000000001698.
- 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
Wirat Klinbuayam, MD principal investigator
Sanpatong Hospital
Jintanat Ananworanich, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
3 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 3 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 4 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 NCT01328275, 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 11 May 2016.