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HIV and Cardiovascular Risk
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), January 2009
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00465426
  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

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Assessment of Cardiovascular Risk in HIV Patients

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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


Estimated Enrollment: 150
Study Start Date: April 2007
Estimated Study Completion Date: April 2011
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 endothelial function 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

Contacts
Contact: Kathleen V Fitch, MSN, NP 617-724-8015 kfitch@partners.org
Contact: Sara Dolan, MSN, NP 617-726-1423 slooby@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Steven K Grinspoon, MD            
Sub-Investigator: Kathleen V Fitch, MSN, NP            
Sub-Investigator: Sara Dolan, MSN, NP            
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Steven K. Grinspoon, MD )
Study ID Numbers: DK49302-10AR
Study First Received: April 24, 2007
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00465426  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
HIV Infection
Cardiovascular Disease
Antiretroviral Therapy
Inflammatory Markers
Treatment Experienced

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
 Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
 Lentivirus Infections
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009



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