Understanding the Increased Risk of Cardiovascular Disease in People With HIV

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00577681
First received: December 17, 2007
Last updated: March 6, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Antiretroviral Therapy (ART)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Lipoproteins, HIV, and Antiretroviral Therapy in SMART

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

The plasma specimens will be collected using EDTA plasma tubes. For each specimen, four transport tubes (Sarstedt 2.0 mL Micro Tube), each containing 1 mL of plasma, will be prepared and labeled with preprinted bar coded labels. The preprinted bar coded labels specify the patient identification code (PID), visit and specimen type, and the protocol and vial ID. Specimens will be frozen at negative 70 degrees Celcius and shipped on dry ice to a central repository, Advanced Biomedical Laboratories, Cinnaminson, New Jersey, where they will be scanned and put into storage. Paperwork documenting the specimens will be processed by the SDMC, and electronic files will be sent to the central repository.


Enrollment: 5472
Study Start Date: January 2002
Study Completion Date: January 2006
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: Anti-HIV therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of life-threatening diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577681

Sponsors and Collaborators
Investigators
Principal Investigator: Daniel A. Duprez, MD, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: Daniel A. Duprez, MD, PhD, University of Minnesota
ClinicalTrials.gov Identifier: NCT00577681     History of Changes
Other Study ID Numbers: 1422, R01 HL090934-01
Study First Received: December 17, 2007
Last Updated: March 6, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
HIV
Lipoproteins
Inflammatory Markers
Coagulation Markers
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014