Understanding the Increased Risk of Cardiovascular Disease in People With HIV

October 30, 2019 updated by: University of Minnesota

Lipoproteins, HIV, and Antiretroviral Therapy in SMART

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. Previous studies indicate that episodic use of ART is associated with increased risk of cardiovascular disease (CVD). This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HIV is a virus that can lead to AIDS, a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Using ART treatments, people with HIV have been able to delay HIV replication and immune system deterioration and to improve quality of life. Data from the Strategies for Management of Antiretroviral Therapy (SMART) study indicate that episodic use of ART is associated with a higher risk of CVD than is continuous use of ART. The reasons behind this increased risk of CVD in the presence of HIV are not well understood. This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

This ancillary study to SMART will use relevant data and specimens from three subsamples of SMART participants and key subgroups. The three subsamples include participants randomly assigned to episodic or continuous ART, participants who had no previous use of ART prior to study entry or had ceased ART within 6 months prior to study entry, and participants who had experienced a CVD event with two matched controls for each case. The subgroups will include episodic and continuous ART participants who were taking either a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) at study entry.

This current study will use previously collected SMART data. Researchers will use data on CD4+ count and HIV-RNA levels from a prebaseline study visit and follow-up study visits that occurred at Months 1 and 2, then every 2 months for Year 1, and every 4 months thereafter during the SMART study. In addition, this study will use baseline and yearly data provided by SMART participants on CVD risk factors and treatment, including use of drug treatments for high blood pressure, diabetes history, cholesterol levels, smoking history, white blood cell count, and height and weight measurements. Last, using plasma specimens that were collected at baseline, the Month 1 follow-up, and the final follow-up, researchers will compare changes in lipoprotein particle size and numbers, as measured by nuclear magnetic resonance (NMR) spectroscopy, and changes in inflammatory and coagulation markers.

Study Type

Observational

Enrollment (Actual)

5472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will utilize patient data and specimens already collected from the previous parent study, SMART.

Description

Inclusion Criteria:

  • Participant in the SMART study
  • CD4+ lymphocyte count greater than 350 cells/mm3

Exclusion Criteria:

  • Presence of life-threatening diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Participants from the SMART study who were randomly assigned to episodic or continuous ART and who have no history of CVD
Drug: Antiretroviral Therapy (ART)
Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.
Other Names:
  • Anti-HIV therapy
2
Participants from the SMART study who were randomly assigned to episodic or continuous ART and who experienced a major CVD event during the study, analyzed along with 2 matched controls
Drug: Antiretroviral Therapy (ART)
Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.
Other Names:
  • Anti-HIV therapy
3
Participants from the SMART study who have no previous use of ART or have taken ART but not done so within 6 months prior to study entry; allows for a comparison of immediate ART versus deferred ART
Drug: Antiretroviral Therapy (ART)
Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.
Other Names:
  • Anti-HIV therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lipoprotein particles size and number
Time Frame: Measured at baseline, Month 1 follow-up visit, and last follow-up visit
Measured at baseline, Month 1 follow-up visit, and last follow-up visit
Change in inflammatory and coagulation markers
Time Frame: Measured at baseline, Month 1 follow-up visit, and last follow-up visit
Measured at baseline, Month 1 follow-up visit, and last follow-up visit
Reasons for increased CVD risk among HIV-infected individuals
Time Frame: Measured at study treatment completion
Measured at study treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Daniel A. Duprez, MD, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0708M14181
  • R01HL090934 (U.S. NIH Grant/Contract)
  • R01HL090934-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Antiretroviral Therapy (ART)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe