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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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

Other trials in Thailand

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 groups in NCT01634477
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.

Jan 2010Jul 2021

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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

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

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
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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.

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?

On the ClinicalTrials.gov record for NCT01634477.

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; AzTrials last refreshed its copy on 8 Nov 2026.