Clinical trial NCT01634477: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study
Official title: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: HIV Netherlands Australia Thailand Research Collaboration
name: Bamrasnaradura Infectious Diseases Institute
name: Chulalongkorn University
name: Queen Savang Vadhana Memorial Hospital, Thailand
First posted: 2012-07-06
Enrollment: 816
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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 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

Primary outcomes:
measure: morbidity
timeFrame: 60 months
measure: HIV related illness
timeFrame: 60 months
measure: Non HIV-related illness
timeFrame: 60 months
measure: mortality
timeFrame: 60 months
measure: CVD
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
affiliation: The Thai Red Cross AIDS Research Centre
name: Praphan Phanuphak, MD
role: PRINCIPAL_INVESTIGATOR
References: