HIV and Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00465426
First received: April 24, 2007
Last updated: October 30, 2012
Last verified: October 2012

April 24, 2007
October 30, 2012
April 2007
November 2011   (final data collection date for primary outcome measure)
  • Carotid Intima Media Thickness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Lipid levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00465426 on ClinicalTrials.gov Archive Site
  • Inflammatory markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Visceral adiposity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
HIV and Cardiovascular Risk
Assessment of Cardiovascular Risk in HIV Patients

HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we will investigate progression rates of cardiovascular disease and assess whether these progression rates are predicted by increased inflammatory indices.

HIV-infected patients treated with combination antiretroviral (ARV) therapy increasingly demonstrate metabolic abnormalities, including dyslipidemia, insulin resistance and body composition abnormalities that may predispose them to cardiovascular disease (CVD). Initial studies suggest increased carotid intima-media thickness (IMT) and endothelial dysfunction in this population. Increased carotid IMT over time has been demonstrated in HIV-infected patients compared to control subjects. However, traditional risk factors, such as dyslipidemia, diabetes mellitus and body composition changes alone do not fully predict increased cardiovascular disease in HIV-infected patients. One possible explanation is increased inflammation, related directly to effects of ARV therapy or indirectly from changes in fat distribution. In preliminary studies, our group has shown that changes in fat distribution were highly predictive of TNF and IL-6, as well as adiponectin, and that specific inflammatory cytokines were related in cross-sectional studies to increased IMT. In the proposed study we will investigate using detailed methodologies the relationship between adipocytokine concentrations and subclinical atherosclerosis in both cross-sectional and longitudinal studies. We will determine in HIV-infected patients on ARVs for greater than 6 months, progression rates of IMT and whether progression rates are predicted by increased inflammatory indices, controlling for traditional risk factors, and body composition changes. We will test the hypothesis that inflammation, more than traditional risk factors and ARV use, mediates subclinical atherosclerotic disease in HIV-infected patients.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood will be frozen for end of study analysis for insulin, CRP, adiponectin, TNF-α, sTNFR2, IL-6, PAI-1, MCP-1

Probability Sample

Flyers and advertisements regarding this study will be posted in community centers and newspapers

  • HIV Infections
  • Cardiovascular Disease
Not Provided
  • 1
    HIV Positive men and women 18-65 years of age
  • 2
    HIV negative men and women 18-65 years of age
Fitch KV, Stavrou E, Looby SE, Hemphill L, Jaff MR, Grinspoon SK. Associations of cardiovascular risk factors with two surrogate markers of subclinical atherosclerosis: endothelial function and carotid intima media thickness. Atherosclerosis. 2011 Aug;217(2):437-40. doi: 10.1016/j.atherosclerosis.2011.04.009. Epub 2011 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria for Group 1 (HIV-infected group)

  1. Age greater than or equal to 18 and less than or equal to 65 years of age
  2. HIV positive, on the same combination ARV regimen for > than 6 months, including but not limited to either 2 NRTIs and an NNRTI or PI, or a triple NRTI regimen
  3. CD4 >350 cells/mm3

Inclusion Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)

  1. No history of HIV infection (negative HIV test)
  2. Age greater than or equal to 18 and less than or equal to 65 years of age

Exclusion Criteria:

Exclusion Criteria for Group 1 (HIV-infected group)

  1. Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN
  2. Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months
  3. New antiretroviral regimen within 6 months of study initiation
  4. Active substance abuse
  5. Medications known to affect glucose or body composition
  6. Positive pregnancy test or recently pregnant within the past year or lactating
  7. Presence of active cancers
  8. Acute viral, bacterial or other infections (excluding HIV)
  9. Weight loss in the past 3 months of greater than 10 pounds

Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)

  1. Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN
  2. Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months.
  3. Active substance abuse
  4. Medications known to affect glucose or body composition
  5. Positive pregnancy test or recently pregnant within the past year or lactating
  6. Acute viral, bacterial or other infections
  7. Weight loss in the past 3 months of greater than 10 pounds
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465426
DK49302-10AR, R01DK049302
No
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP