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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Healthy

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 Type: Observational
• Enrollment (Actual): 816

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV-infected patients group; HIV positive
HIV-uninfected patients group; HIV negative

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: Chulalongkorn University; HIV Netherlands Australia Thailand Research Collaboration; Bamrasnaradura Infectious Diseases Institute; Queen Savang Vadhana Memorial Hospital, Thailand
• Investigators: Principal Investigator: Praphan Phanuphak, MD, The Thai Red Cross AIDS Research Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimated): July 6, 2012

Study Record Updates

• Last Update Posted (Actual): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: mortality; morbidity; HIV-infected patients; opportunistic infections; prospective cohort study; cardiovascular disease (CVD); highly active antiretroviral therapy (HAART); Non HIV-related illness; HIV negative patients; Thai HIV-infected patients
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: TNT-HIV 003