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HIV and Cardiovascular Risk

NCT ID: NCT00465426

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Cardiovascular Disease

Keywords

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HIV Infection Cardiovascular Disease Antiretroviral Therapy Inflammatory Markers Treatment Experienced

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

HIV Positive men and women 18-65 years of age

No interventions assigned to this group

2

HIV negative men and women 18-65 years of age

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Steven K. Grinspoon, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven K Grinspoon, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21570076 (View on PubMed)

Other Identifiers

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R01DK049302

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK49302-10AR

Identifier Type: -

Identifier Source: org_study_id