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

Healthy Clinical Trial

— TNT-HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634477
• Other study ID #: TNT-HIV 003
• Status: Completed
• Start date: January 2010
• Est. completion date: July 2021

Study information

• Verified date: July 2021
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 816
• Est. completion date: July 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Healthy
• HIV Infection
• HIV Infections
• Infection

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University, HIV Netherlands Australia Thailand Research Collaboration, Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity	development of other diseases	60 months
Primary	HIV related illness	development of opportunistic infection such as Non-Hodkin's lymphoma, Kaposi's sarcoma	60 months
Primary	Non HIV-related illness	development of Dyslipidemia, Hypertension, DM, CVD , Cancer, osteopenia, osteoporosis, Renal disease, liver disease	60 months
Primary	mortality	death	60 months
Primary	CVD	development of CVD	60 months