Lipid Profile and Diabetes Mellitus in People With HIV

NCT04125784 | Completed DMC

• 1 other identifier: V2_02082019
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional risk factors for cardiovascular diseases have been shown to have an even higher impact in the HIV infected population. The original study from 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (namely, dyslipidaemia and diabetes mellitus) in people living with HIV (PLWHIV) in Austria. The aim of this follow up study is to see the progression of our study sample and to see what prevalence levels may be found after 7 years. This epidemiological evaluation is conceptualized to document real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk and to compare with the baseline values from the original study.

Conditions

HIV Infections; Dyslipidemias; Diabetes Mellitus; Cardiovascular Risk Factor

Keywords

HIV; HIV infection; Dyslipidaemia; Diabetes mellitus; Diabetes mellitus type 2; Cardiovascular Risk factor; Lipid profile; Austria; HIV related treatment; Antiretroviral therapy; Follow-up Study

Outcome Measures

Primary Outcomes (7)

• Changes in dyslipidemia prevalence from baseline - total cholesterol

  Total cholesterol values will be analyzed by an authorized laboratory

  7 years

• Changes in dyslipidemia prevalence from baseline- triglycerides

  Triglyceride values will be analyzed by an authorized laboratory

  7 years

• Changes in dyslipidemia prevalence from baseline - HDL-cholesterol

  HDL-Cholesterol values will be analyzed by an authorized laboratory

  7 years

• Changes in dyslipidemia prevalence from baseline - Apolipoprotein B

  Apolipoprotein B values will be analyzed by an authorized laboratory

  7 years

• Changes in dyslipidemia prevalence from baseline - LDL-cholesterol

  a. LDL will be calculated using the Friedewald formula. As the Friedewald formula does not work in case of triglycerides \> 300, in these patients only non-HDL-C will be used.

  7 years

• Changes in dyslipidemia prevalence from baseline - Non-HDL-Cholesterol

  Non-HDL-Cholesterol will be calculated additionally.

  7 years

• Changes from baseline in diabetes mellitus type II prevalence

  The diabetes mellitus prevalence will be assessed through patient history (checking for a diabetes mellitus type II diagnosis since baseline)

  7 years

Secondary Outcomes (8)

• Description of risk profile for cardiovascular events in the sample population

  at follow up recruitment, Day 0

• Changes from baseline in drug utilization for PLWHIV

  7 years

• Prevalence of diabetes mellitus type 2 in correlation to the prescribed antiretroviral regime during the follow up time

  7 years

• Changes from baseline in the lipid profile of patients in correlation to prescribed antiretroviral regime

  7 years

• Changes from baseline in therapy prescriptions of patients who were found to have hyperlipidaemia during first study in 2014

  7 years

Study Arms (1)

Lipid-profile

The cohort includes male and female patients diagnosed and confirmed HIV diagnosis who receive HIV related treatment in an extramural setting. All patients are adults (older than 18 years old) and have participated in the original study in 2014.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes only participants who participated in the original study from 2014. These patients are all patients who receive HIV related treatment in an extramural setting and visited their ÖGNÄ-HIV physician for routine control in Vienna/Austria. The original inclusion criteria were: adult (older than 18 years) male and female patients diagnosed and confirmed HIV diagnosis, given written informed consent.

You may qualify if:

• Only Participants who participated in the previous study
• Adult (older than 18 years)
• male and female patients diagnosed and confirmed HIV diagnosis, given written informed consent

You may not qualify if:

• No participation in the original study

Sponsors & Collaborators

• Moritz Oberndorfer: lead
• Merck Gesellschaft mbH, Austria: collaborator

Study Sites (1)

Schalk:Pichler Gruppenpraxis

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

HIV Infections; Dyslipidemias; Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Thomas E Dorner, MD, MPH

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 14, 2019
• Study Start: August 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: February 28, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

AU (1)