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Trial record 12 of 16 for:    " April 18, 2007":" May 18, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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HIV and Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  Purpose

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.


Condition
HIV Infections
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Cardiovascular Risk in HIV Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Visceral adiposity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 129
Study Start Date: April 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV Positive men and women 18-65 years of age
2
HIV negative men and women 18-65 years of age

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465426

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00465426     History of Changes
Other Study ID Numbers: DK49302-10AR, R01DK049302
Study First Received: April 24, 2007
Last Updated: October 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
HIV Infection
Cardiovascular Disease
Antiretroviral Therapy
Inflammatory 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 May 23, 2013