HIV InfectionsNCT04125784
Lipid Profile and Diabetes Mellitus in People With HIV
An observational study of HIV Infections and Dyslipidemias, run by Moritz Oberndorfer at 1 site in Austria.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Dyslipidemias, Diabetes Mellitus
- How many people
- 450 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2021to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No participation in the original study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Profile and Diabetes Risk of HIV Patients Treated by Austrian HIV -Physicians: a 7 Year Follow up Study
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.
Read the detailed description
Background: In developed countries, an increase in cardiovascular events and related mortality has been seen; even more prominent in people living with HIV (PLWHIV) as compared to non-HIV control groups. Studies have shown dyslipidaemia and diabetes mellitus type 2 as important risk factors for cardiovascular diseases in PLWHIV.
The original study by this group in 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (dyslipidaemia and diabetes mellitus) in PLWHIV in Austria and identified characteristics associated with these two risk factors. In that previous study dyslipidaemia was diagnosed in 46.3% of cases and half of all the study participants showed an increased insulin resistance. Eight persons (1.6%) fulfilled the criteria for diabetes mellitus type 2.
Purpose: 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. Additionally, a look into previously identified characteristics associated with dyslipidaemia and diabetes mellitus type may provide valuable insight into the temporal effects. Finally, examining resource use this population in terms of medications can provide insights into current practice and its associated costs in Austria, as well as an estimate of the added medication cost of dyslipidaemia and diabetes mellitus type 2 in this population.
It is our aim to close the existing knowledge gap on the role of dyslipidaemia and diabetes mellitus on cardiovascular risk among PLWHIV in Austria. Therefore, the investigation will be carried out by using routine data within minimum additional effort to the study team. The data obtained may serve as a base for future decisions on treatment of the Austrian HIV population.
Study details: Our epidemiologic evaluation documents real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk. The gathered data from approximately 450 originally enrolled patients will be compared with the baseline values analysed in the original study in 2014.
Data collection: Dataset definitions and the minimum dataset will be determined by the study authors. Parameters used and documented must match those that were taken in the original study. These were specified in the case report form (CRF). The data collection and preparation will be done by a student of the Medical University of Vienna (Department of Social and Preventive Medicine) as a part of the graduate thesis.
Enrolment Strategy: Patients will be recruited through the original study sites (2 extramural HIV clinics in Vienna). Original patient lists will be screened through the official Mortality Register of the Statistics Austria, where patients who have died during the follow up period will be identified. Additionally, other patients who decline participation will be asked to give reasons of declining participation.
Data Validation and Data quality: Accurate data are crucial contributors to informative statistical analyses. Missing data will not be systematized.
Quality Control: Source documentation and data accuracy will be verified by site visit(s) in 1 randomly selected site after termination of the enrolment period. 10% of case report forms of the reviewed site will be randomly selected for monitoring.
- 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
- Medical subject headings
- HIV Infections, Dyslipidemias, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dyslipidemia prevalence from baseline - total cholesterol
Total cholesterol values will be analyzed by an authorized laboratory
Measured: 7 years
Changes in dyslipidemia prevalence from baseline- triglycerides
Triglyceride values will be analyzed by an authorized laboratory
Measured: 7 years
Changes in dyslipidemia prevalence from baseline - HDL-cholesterol
HDL-Cholesterol values will be analyzed by an authorized laboratory
Measured: 7 years
Changes in dyslipidemia prevalence from baseline - Apolipoprotein B
Apolipoprotein B values will be analyzed by an authorized laboratory
Measured: 7 years
Changes in dyslipidemia prevalence from baseline - LDL-cholesterol
- 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.
Measured: 7 years
Changes in dyslipidemia prevalence from baseline - Non-HDL-Cholesterol
Non-HDL-Cholesterol will be calculated additionally.
Measured: 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)
Measured: 7 years
Secondary outcomes (8)
Description of risk profile for cardiovascular events in the sample population
The cardiovascular risk will be assessed through the European Society of Cardiology (ESC) calculator. Therefore, the risk profile for cardiovascular events will be assessed through documentation of risk factors (sex, age, smoking status, history of diabetes, hypertension, dyslipidaemia, previous cardiovascular events, other comorbidities) and laboratory parameters on the CRF by the investigator.
Measured: at follow up recruitment, Day 0
Changes from baseline in drug utilization for PLWHIV
Drug utilization will be assessed through documentation on the CRF by the investigator
Measured: 7 years
Prevalence of diabetes mellitus type 2 in correlation to the prescribed antiretroviral regime during the follow up time
Diabetes mellitus type 2 will be assessed from patient history
Measured: 7 years
Changes from baseline in the lipid profile of patients in correlation to prescribed antiretroviral regime
Lipid profile will be assessed with laboratory parameters (total cholesterol, triglycerides, HDL, Apolipoprotein B). LDL will be calculated using the Friedewald formula, additionally, non-HDL-Cholesterol (Non-HDL-C) will be calculated . As the Friedewald formula does not work in case of triglycerides > 300, in these patients only Non-HDL-C will be used.
Measured: 7 years
Changes from baseline in therapy prescriptions of patients who were found to have hyperlipidaemia during first study in 2014
Therapy prescriptions will be assessed through documentation of the patient's medication on the CRF by the investigator.
Measured: 7 years
Documentation of any major cardiovascular events (stroke or heart attack)
Cardiovascular events (stroke or heart attack) will be assessed through documentation on the CRF by the investigator.
Measured: during 7 years
Incidence of diabetes mellitus type 2 in patients who were diagnosed found to be insulin resistant in the first study in 2014
Self reported diagnosis or presence of diabetes type 2 medication as noted in the CRF
Measured: 7 years
Changes from baseline in therapeutic regimes within those patients who were identified as having diabetes mellitus type 2 in the first study in 2014
Therapeutic regimes will be assessed through documentation of the patient's medication on the CRF by the investigator.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Aug 2021
- Primary completion30 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moritz Oberndorfer
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Gesellschaft mbH, Austria
- Responsible party
- Sponsor-investigator, Moritz Oberndorfer, Medical University of Vienna
- Investigators
- Thomas E Dorner, MD, MPH, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125784
- Sponsor's protocol ID
- V2_02082019
- Status last verified
- Mar 2023
- First submitted
- 9 Oct 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised and limited data set may be given to other researchers upon request from the principal investigator, following compliance of the Data Security Department of the Medical University of Vienna.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profile and Diabetes Risk of HIV Patients Treated by Austrian HIV -Physicians: a 7 Year Follow up Study
- ClinicalTrials.gov ID
- NCT04125784
- Acronym / sponsor ID
- V2_02082019
- Keywords
- HIV, HIV infection, Dyslipidaemia, Diabetes mellitus, Diabetes mellitus type 2, Cardiovascular Risk factor, Lipid profile, Austria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Moritz OberndorferUniversity, hospital or other
- Collaborators
- Merck Gesellschaft mbH, Austria
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: In developed countries, an increase in cardiovascular events and related mortality has been seen; even more prominent in people living with HIV (PLWHIV) as compared to non-HIV control groups. Studies have shown dyslipidaemia and diabetes mellitus type 2 as important risk factors for cardiovascular diseases in PLWHIV.
The original study by this group in 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (dyslipidaemia and diabetes mellitus) in PLWHIV in Austria and identified characteristics associated with these two risk factors. In that previous study dyslipidaemia was diagnosed in 46.3% of cases and half of all the study participants showed an increased insulin resistance. Eight persons (1.6%) fulfilled the criteria for diabetes mellitus type 2.
Purpose: 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. Additionally, a look into previously identified characteristics associated with dyslipidaemia and diabetes mellitus type may provide valuable insight into the temporal effects. Finally, examining resource use this population in terms of medications can provide insights into current practice and its associated costs in Austria, as well as an estimate of the added medication cost of dyslipidaemia and diabetes mellitus type 2 in this population.
It is our aim to close the existing knowledge gap on the role of dyslipidaemia and diabetes mellitus on cardiovascular risk among PLWHIV in Austria. Therefore, the investigation will be carried out by using routine data within minimum additional effort to the study team. The data obtained may serve as a base for future decisions on treatment of the Austrian HIV population.
Study details: Our epidemiologic evaluation documents real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk. The gathered data from approximately 450 originally enrolled patients will be compared with the baseline values analysed in the original study in 2014.
Data collection: Dataset definitions and the minimum dataset will be determined by the study authors. Parameters used and documented must match those that were taken in the original study. These were specified in the case report form (CRF). The data collection and preparation will be done by a student of the Medical University of Vienna (Department of Social and Preventive Medicine) as a part of the graduate thesis.
Enrolment Strategy: Patients will be recruited through the original study sites (2 extramural HIV clinics in Vienna). Original patient lists will be screened through the official Mortality Register of the Statistics Austria, where patients who have died during the follow up period will be identified. Additionally, other patients who decline participation will be asked to give reasons of declining participation.
Data Validation and Data quality: Accurate data are crucial contributors to informative statistical analyses. Missing data will not be systematized.
Quality Control: Source documentation and data accuracy will be verified by site visit(s) in 1 randomly selected site after termination of the enrolment period. 10% of case report forms of the reviewed site will be randomly selected for monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No participation in the original study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in dyslipidemia prevalence from baseline - total cholesterol
Time frame: 7 years
Total cholesterol values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline- triglycerides
Time frame: 7 years
Triglyceride values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - HDL-cholesterol
Time frame: 7 years
HDL-Cholesterol values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - Apolipoprotein B
Time frame: 7 years
Apolipoprotein B values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - LDL-cholesterol
Time frame: 7 years
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.
Changes in dyslipidemia prevalence from baseline - Non-HDL-Cholesterol
Time frame: 7 years
Non-HDL-Cholesterol will be calculated additionally.
Changes from baseline in diabetes mellitus type II prevalence
Time frame: 7 years
The diabetes mellitus prevalence will be assessed through patient history (checking for a diabetes mellitus type II diagnosis since baseline)
8 secondary outcomes
Description of risk profile for cardiovascular events in the sample population
Time frame: at follow up recruitment, Day 0
Changes from baseline in drug utilization for PLWHIV
Time frame: 7 years
Prevalence of diabetes mellitus type 2 in correlation to the prescribed antiretroviral regime during the follow up time
Time frame: 7 years
Changes from baseline in the lipid profile of patients in correlation to prescribed antiretroviral regime
Time frame: 7 years
Changes from baseline in therapy prescriptions of patients who were found to have hyperlipidaemia during first study in 2014
Time frame: 7 years
Documentation of any major cardiovascular events (stroke or heart attack)
Time frame: during 7 years
Incidence of diabetes mellitus type 2 in patients who were diagnosed found to be insulin resistant in the first study in 2014
Time frame: 7 years
Changes from baseline in therapeutic regimes within those patients who were identified as having diabetes mellitus type 2 in the first study in 2014
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: Undecided. Anonymised and limited data set may be given to other researchers upon request from the principal investigator, following compliance of the Data Security Department of the Medical University of Vienna.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Dorner, MD, MPH principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Dyslipidemias, run by Moritz Oberndorfer at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dyslipidemia prevalence from baseline - total cholesterol (time frame: 7 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.