Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients (Quad)
This study is currently recruiting participants.
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01766726
First received: January 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction as a mechanism of improved plaque inflammation/vulnerability.
| Condition |
|---|
|
HIV |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
Secondary Outcome Measures:
- Aortic/coronary atherosclerotic plaque on coronary computed tomography angiography (coronary CTA) [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]Aortic/coronary atherosclerotic plaque assessed via coronary CTA.
- Lipid and lipoprotein levels [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]Levels of lipids and lipoproteins including but not limited to levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and levels select apolipoprotein levels.
- Indices of pro-atherogenic lipid dysfunction [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]HDL oxidative potential.
- Inflammatory biomarker levels [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]Levels of inflammatory biomarkers including but not limited to soluble CD163.
- Percentage of circulating activated leukocyte subsets [ Time Frame: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild ] [ Designated as safety issue: No ]Percentage of circulating activated leukocyte subsets including but not limited to percentage of circulating CD14+CD16+ monocytes assessed via flow cytometry.
Biospecimen Retention: Samples Without DNA
Plasma, serum.
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Historical healthy control subjects
Historical healthy control subjects matched to HIV+ patients on traditional cardiovascular risk factors will be studied at baseline.
|
|
ART-naïve HIV+ patients starting QUAD/Stribild
ART-naïve HIV+ patients who are about to be started QUAD/Stribild by their treating clinicians will be studied at baseline and 6 months after initiating QUAD/Stribild therapy.
|
Detailed Description:
Patients with HIV are at higher risk of morbidity and mortality from cardiovascular disease than healthy subjects. Antiretroviral therapy (ART) has greatly increased the lifespan of HIV+ patients, but their risk of CVD remains higher than normal. Previously, it has been shown that compared to healthy control subjects, ART-treated HIV+ patients have more atherosclerotic plaque inflammation in the aorta. This study is intended to determine whether atherosclerotic plaque inflammation/vulnerability is increased in ART-naïve HIV+ patients and whether these parameters can be improved through 6 months of newly-initiated QUAD/Stribild therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with HIV infection being cared for in the Eastern Massachusetts area may be appprised of the study by their treating infectious disease doctors. Additionally, subjects with HIV infection from the community will be recruited via posters, advertisements, e-postings.
Criteria
Inclusion Criteria:
- men and women, ages 18+, with documented HIV-infection who are ART-naive and ready to be started on ART with QUAD/Stribild by their treating infectious disease doctors
Exclusion Criteria:
- history of prior, sustained ART use
- CD4 <50 or AIDS-defining illness
- known current opportunistic infection or acute infections (not including Hepatitis B/C)
- pregnancy or breastfeeding
- history of acute coronary syndrome or coronary artery stenting or surgery, diabetes mellitus, or significant autoimmune/inflammatory disease
- plans for sustained use during 6 month study interval of a confounding immune suppressant medication including intravenous or oral corticosteroid
- hemoglobin < 12.5 for men or < 12 for women
- eGFR < 70 ml/min/1.73 m2 calculated by CDK-EPI
- contrast dye allergy
- contraindication to beta blockers or nitroglycerin administered during MDCT coronary angiography (coronary CTA) protocol
- body weight > 320 lbs (PET scanner limitation)
- significant radiation exposure (>2 myocardial perfusion scans or CT angiograms) received within the past year
- reported active illicit drug use
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766726
Contacts
| Contact: Steven K Grinspoon, MD | 617-724-9109 | sgrinspoon@partners.org |
| Contact: Markella V Zanni, MD | 617-724-6926 | mzanni@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Steven K Grinspoon, MD 617-724-9109 sgrinspoon@partners.org | |
| Contact: Markella V Zanni, MD 617-724-6926 mzanni@partners.org | |
Sponsors and Collaborators
Massachusetts General Hospital
Gilead Sciences
Investigators
| Principal Investigator: | Steven K Grinspoon, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Steven K. Grinspoon, MD, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01766726 History of Changes |
| Other Study ID Numbers: | 2012P001138 |
| Study First Received: | January 9, 2013 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
HIV Atherosclerosis |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013