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CompletedNCT01634477TNT-HIVUpdated Nov 25, 2024

Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study

An observational study in HIV Infection and Healthy, sponsored by Thai Red Cross AIDS Research Centre. Completed at 1 site in Thailand. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Thai Red Cross AIDS Research Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
816
Ages
30 Years and older
Sex
All
01

Study 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. To describe the mortality among HIV-infected patients and HIV-uninfected patients.
  4. 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.

02

Conditions studied

  • 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
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 816 is above the median of 200 across 731 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Thai Red Cross AIDS Research Centre is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

  • HIV un-infected
  • 30 years of age or older, both male and female
  • Thai nationality
  • Written research informed consent

Exclusion criteria

Exclusion Criteria:

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
  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
816 participants (actual)

Groups and cohorts

  • HIV-infected patients group

    HIV positive

  • HIV-uninfected patients group

    HIV negative

06

What researchers measure

Primary outcomes

  1. morbidity

    development of other diseases

    Time frame: 60 months

  2. HIV related illness

    development of opportunistic infection such as Non-Hodkin's lymphoma, Kaposi's sarcoma

    Time frame: 60 months

  3. Non HIV-related illness

    development of Dyslipidemia, Hypertension, DM, CVD , Cancer, osteopenia, osteoporosis, Renal disease, liver disease

    Time frame: 60 months

  4. mortality

    death

    Time frame: 60 months

  5. CVD

    development of CVD

    Time frame: 60 months

07

Study locations

1 site
  • The Thai Red Cross AIDS Research Centre
    Pathum Wan, Bangkok 10330, Thailand
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Oct 2020 and a completion of Jul 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2012
First posted
Jul 6, 2012
Start
Jan 2010
Primary completionActual
Oct 2020
CompletionActual
Jul 2021
Last update
Nov 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01634477
Lead sponsor
Thai Red Cross AIDS Research Centre
Collaborators
HIV Netherlands Australia Thailand Research Collaboration, Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University, Queen Savang Vadhana Memorial Hospital, Thailand
Responsible party
Sponsor
First posted
Jul 6, 2012
Start date
Jan 2010
Primary completion
Oct 2020
Completion
Jul 2021
Last update
Nov 25, 2024

Study contacts

Praphan Phanuphak, MD
principal investigator · Thai Red Cross AIDS Research Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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