NCT01634477

Brief Summary

  1. 1.To describe the morbidity and clinical characteristics among HIV-infected patients and HIV-uninfected patients.
  2. 2.To identify the risk factors for the complication or morbidity among HIV-infected patients and HIV-uninfected patients.
  3. 3.To describe the mortality among HIV-infected patients and HIV-uninfected patients.
  4. 4.To identify the risk factors for the cause of death among HIV-infected and HIV-uninfected patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
816

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 25, 2024

Status Verified

July 1, 2021

Enrollment Period

10.8 years

First QC Date

July 2, 2012

Last Update Submit

November 22, 2024

Conditions

HIV InfectionHealthy

Keywords

morbiditymortalityHIV-infected patientsprospective cohort studyhighly active antiretroviral therapy (HAART)opportunistic infectionsNon HIV-related illnesscardiovascular disease (CVD)HIV negative patientsThai HIV-infected patients

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

HIV-infected patients group

HIV positive

HIV-uninfected patients group

HIV negative

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV InfectionsOpportunistic InfectionsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Praphan Phanuphak, MD

    The Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

January 1, 2010

Primary Completion

October 1, 2020

Study Completion

July 1, 2021

Last Updated

November 25, 2024

Record last verified: 2021-07

Locations

TH(1)