An observational study in HIV Infections, sponsored by University of Minnesota. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Observational
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 5,472 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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This study will utilize patient data and specimens already collected from the previous parent study, SMART.
Exclusion Criteria:
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)
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)
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.
Also known as: Anti-HIV therapy
Change in lipoprotein particles size and number
Time frame: 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
Reasons for increased CVD risk among HIV-infected individuals
Time frame: Measured at study treatment completion
No study locations are listed for this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Minnesota