HIV InfectionTNT-HIVNCT01634477
Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study
An observational study of HIV Infection and Healthy, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
1. To describe the morbidity and clinical characteristics among HIV-infected patients and HIV-uninfected patients. 2. To identify the risk factors for the complication or morbidity among HIV-infected patients and HIV-uninfected patients. 3. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Healthy
- How many people
- 816 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Jul 2021
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thai HIV-infected patients with and without ART, and HIV negative patients from the Thai Red Cross AIDS Research Centre and Queen Savang Memorial Hospital Institute during January 2010 - December 2014
Who may be able to join
- HIV-infected patients group
- HIV positive
- 30 years of age or older, both male and female
- Thai nationality
- Written research informed consent
- HIV-uninfected patients group
Show all 10Show fewer
- HIV un-infected
- 30 years of age or older, both male and female
- Thai nationality
- Written research informed consent
Who cannot join
- HIV-infected patients group
- Systolic BP ≥ 130 or Diastolic BP ≥ 85mm Hg or on the treatment
- Fasting blood sugar > 126 mg/dl or on the treatment
- Proteinuria
- Creatinine > 1.5 mg/dl
- Recent hospitalization
Show all 13Show fewer
- Patient who are having mental disease HIV-uninfected patients group
- Systolic BP ≥ 130 or Diastolic BP ≥ 85mm Hg or on the treatment
- Fasting blood sugar > 126 mg/dl or on the treatment
- Proteinuria
- Creatinine > 1.5 mg/dl
- Recent hospitalization
- Patient who are having mental disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
About this study
- To describe the morbidity and clinical characteristics among HIV-infected patients and HIV-uninfected patients.
- To identify the risk factors for the complication or morbidity among HIV-infected patients and HIV-uninfected patients.
- To describe the mortality among HIV-infected patients and HIV-uninfected patients.
- To identify the risk factors for the cause of death among HIV-infected and HIV-uninfected patients.
Read the detailed description
The information obtained from this study would be very important in planning future holistic care of HIV-infected patients in our institutes as well as in national policy. Results from the study could be used to develop proper long-term management guidelines for people living with HIV (PLHIV) in Thailand targeted at preventable conditions such as metabolic diseases and certain cancers.
- Conditions
- HIV Infection, Healthy
- Keywords
- morbidity, mortality, HIV-infected patients, prospective cohort study, highly active antiretroviral therapy (HAART), opportunistic infections, Non HIV-related illness, cardiovascular disease (CVD), HIV negative patients, Thai HIV-infected patients
- Medical subject headings
- HIV Infections, Opportunistic Infections, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected patients group | HIV positive | |
| HIV-uninfected patients group | HIV negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
development of other diseases
Measured: 60 months
HIV related illness
development of opportunistic infection such as Non-Hodkin's lymphoma, Kaposi's sarcoma
Measured: 60 months
Non HIV-related illness
development of Dyslipidemia, Hypertension, DM, CVD , Cancer, osteopenia, osteoporosis, Renal disease, liver disease
Measured: 60 months
mortality
death
Measured: 60 months
CVD
development of CVD
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- HIV Netherlands Australia Thailand Research Collaboration, Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University, Queen Savang Vadhana Memorial Hospital, Thailand
- Responsible party
- Sponsor
- Investigators
- Praphan Phanuphak, MD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634477
- Sponsor's protocol ID
- TNT-HIV 003
- Acronym
- TNT-HIV
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2012
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01634477
- Acronym / sponsor ID
- TNT-HIV / TNT-HIV 003
- Conditions
- HIV Infection, Healthy
- Keywords
- morbidity, mortality, HIV-infected patients, prospective cohort study, highly active antiretroviral therapy (HAART), opportunistic infections, Non HIV-related illness, cardiovascular disease (CVD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- HIV Netherlands Australia Thailand Research Collaboration, Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University, Queen Savang Vadhana Memorial Hospital, Thailand
- Study start
- Jan 2010
- Primary completion
- Oct 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 6 Jul 2012 (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.
- To describe the morbidity and clinical characteristics among HIV-infected patients and HIV-uninfected patients.
- To identify the risk factors for the complication or morbidity among HIV-infected patients and HIV-uninfected patients.
- To describe the mortality among HIV-infected patients and HIV-uninfected patients.
- To identify the risk factors for the cause of death among HIV-infected and HIV-uninfected patients.
Detailed description
The information obtained from this study would be very important in planning future holistic care of HIV-infected patients in our institutes as well as in national policy. Results from the study could be used to develop proper long-term management guidelines for people living with HIV (PLHIV) in Thailand targeted at preventable conditions such as metabolic diseases and certain cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected patients group | – | –HIV positive |
| HIV-uninfected patients group | – | –HIV negative |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thai HIV-infected patients with and without ART, and HIV negative patients from the Thai Red Cross AIDS Research Centre and Queen Savang Memorial Hospital Institute during January 2010 - December 2014
Key inclusion criteria (10 listed)
- HIV-infected patients group
- HIV positive
- 30 years of age or older, both male and female
- Thai nationality
- Written research informed consent
Key exclusion criteria (13 listed)
- HIV-infected patients group
- Systolic BP ≥ 130 or Diastolic BP ≥ 85mm Hg or on the treatment
- Fasting blood sugar > 126 mg/dl or on the treatment
- Proteinuria
- Creatinine > 1.5 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
morbidity
Time frame: 60 months
development of other diseases
HIV related illness
Time frame: 60 months
development of opportunistic infection such as Non-Hodkin's lymphoma, Kaposi's sarcoma
Non HIV-related illness
Time frame: 60 months
development of Dyslipidemia, Hypertension, DM, CVD , Cancer, osteopenia, osteoporosis, Renal disease, liver disease
mortality
Time frame: 60 months
death
CVD
Time frame: 60 months
development of CVD
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 25 Nov 2024.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Praphan Phanuphak, MD principal investigator
Thai Red Cross AIDS Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Healthy, run by Thai Red Cross AIDS Research Centre at 1 site 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 10 inclusion and 13 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
morbidity (time frame: 60 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.