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

This study is currently recruiting participants.
Verified July 2012 by Thai Red Cross AIDS Research Centre
Sponsor:
Collaborators:
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital, Thailand
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT01634477
First received: July 2, 2012
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose
  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.

Condition
HIV Infection
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • morbidity [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of other diseases

  • HIV related illness [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of opportunistic infection such as Non-Hodkin's lymphoma, Kaposi's sarcoma

  • Non HIV-related illness [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of Dyslipidemia, Hypertension, DM, CVD , Cancer, osteopenia, osteoporosis, Renal disease, liver disease

  • mortality [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    death

  • CVD [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of CVD


Estimated Enrollment: 816
Study Start Date: January 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected patients group
HIV positive
HIV-uninfected patients group
HIV negative

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634477

Contacts
Contact: Jureeporn Jantarapakde +662-253-0997 jureepornj@trcarc.org
Contact: Nittaya Phanuphak +662-253-0996 nittaya.p@trcarc.org

Locations
Thailand
The Thai Red Cross AIDS Research Centre Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Nittaya Phanuphak, MD     +662 253 0996     nittaya.p@trcarc.org    
Contact: Jureeporn Jantarapakde     +662 253 0997     jureepornj@trcarc.org    
Principal Investigator: Praphan Phanuphak            
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital, Thailand
Investigators
Principal Investigator: Praphan Phanuphak, MD The Thai Red Cross AIDS Research Centre
  More Information

No publications provided

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01634477     History of Changes
Other Study ID Numbers: TNT-HIV 003
Study First Received: July 2, 2012
Last Updated: July 5, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Thai Red Cross AIDS Research Centre:
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013