Back to resultsUse of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Primary Purpose
HIV Infections, Heart Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rosuvastatin 10 mg. daily for 96 weeks
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, Heart Disease, Bone Density
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of HIV Disease
- Age > 18 years old
- Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
- Fasting LDL cholesterol < 130 mg/dl
- Fasting triglycerides < 300 mg/dL
- hsCRP > 2 mg/L or CD38+DR+/CD8+ > 19%
- If on Vit D replacement therapy, stable regimen for > 3 months prior to study entry
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Any active or chronic inflammatory condition
- Cardiovascular disease
- Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
- Uncontrolled hypothyroidism or hyperthyroidism
- Uncontrolled diabetes
- Use of systemic cancer chemotherapy of immunomodulating agents
- Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
- Use of biphosphonates or other bone therapies
Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
- AST and/or ALT > 2.5 x ULN
- Hemoglobin < 9.0 g/dL
- CK > 3 X ULN
- Calculated creatinine clearance < 50 mL/min
Sites / Locations
- University Hospitals of Cleveland Case Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rosuvastatin
Sugar Pill placebo
Arm Description
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Outcomes
Primary Outcome Measures
Bone Mineral Density (BMD)
Measured by change in bone DEXA from baseline to week 96
Carotid IMT
changes in carotid IMT is a good measure for cardiovascular disease progression
Secondary Outcome Measures
Full Information
NCT ID
NCT01218802
First Posted
October 8, 2010
Last Updated
March 3, 2016
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
National Institutes of Health (NIH), AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01218802
Brief Title
Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Official Title
Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
National Institutes of Health (NIH), AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.
Detailed Description
While the use of antiretroviral therapy (ART) in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, nevertheless, cardiovascular disease is a major concern impacting morbidity and mortality in this population.
This study will assess if a potent statin, rosuvastatin, could improve endothelial dysfunction, slow carotid intima media thickness (IMT) progression and bone loss, and decrease inflammation and oxidative stress in HIV-infected ART-treated subjects with good HIV virologic control. The investigators will also see if rosuvastatin will induce beneficial changes in the prevalence of metabolic syndrome and lipid metabolism as well as improve bone turnover markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Heart Disease
Keywords
HIV, Heart Disease, Bone Density
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Arm Title
Sugar Pill placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10 mg. daily for 96 weeks
Other Intervention Name(s)
Crestor
Intervention Description
Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
participants will take a sugar pill daily for 96 weeks
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD)
Description
Measured by change in bone DEXA from baseline to week 96
Time Frame
96 weeks
Title
Carotid IMT
Description
changes in carotid IMT is a good measure for cardiovascular disease progression
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of HIV Disease
Age > 18 years old
Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
Fasting LDL cholesterol < 130 mg/dl
Fasting triglycerides < 300 mg/dL
hsCRP > 2 mg/L or CD38+DR+/CD8+ > 19%
If on Vit D replacement therapy, stable regimen for > 3 months prior to study entry
Exclusion Criteria:
Women who are pregnant or breast feeding
Any active or chronic inflammatory condition
Cardiovascular disease
Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
Uncontrolled hypothyroidism or hyperthyroidism
Uncontrolled diabetes
Use of systemic cancer chemotherapy of immunomodulating agents
Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
Use of biphosphonates or other bone therapies
Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
AST and/or ALT > 2.5 x ULN
Hemoglobin < 9.0 g/dL
CK > 3 X ULN
Calculated creatinine clearance < 50 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace McComsey, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29908359
Citation
El Kamari V, Hileman CO, Gholam PM, Kulkarni M, Funderburg N, McComsey GA. Statin Therapy Does Not Reduce Liver Fat Scores in Patients Receiving Antiretroviral Therapy for HIV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):536-542.e1. doi: 10.1016/j.cgh.2018.05.058. Epub 2018 Jun 14.
Results Reference
derived
PubMed Identifier
26455521
Citation
Dirajlal-Fargo S, Webel AR, Longenecker CT, Kinley B, Labbato D, Sattar A, McComsey GA. The effect of physical activity on cardiometabolic health and inflammation in treated HIV infection. Antivir Ther. 2016;21(3):237-45. doi: 10.3851/IMP2998. Epub 2015 Oct 12.
Results Reference
derived
PubMed Identifier
26372274
Citation
Hale AT, Longenecker CT, Jiang Y, Debanne SM, Labatto DE, Storer N, Hamik A, McComsey GA. HIV vasculopathy: role of mononuclear cell-associated Kruppel-like factors 2 and 4. AIDS. 2015 Aug 24;29(13):1643-50. doi: 10.1097/QAD.0000000000000756.
Results Reference
derived
PubMed Identifier
26269240
Citation
Hileman CO, Dirajlal-Fargo S, Lam SK, Kumar J, Lacher C, Combs GF Jr, McComsey GA. Plasma Selenium Concentrations Are Sufficient and Associated with Protease Inhibitor Use in Treated HIV-Infected Adults. J Nutr. 2015 Oct;145(10):2293-9. doi: 10.3945/jn.115.214577. Epub 2015 Aug 12.
Results Reference
derived
PubMed Identifier
26157049
Citation
Erlandson KM, Jiang Y, Debanne SM, McComsey GA. Rosuvastatin Worsens Insulin Resistance in HIV-Infected Adults on Antiretroviral Therapy. Clin Infect Dis. 2015 Nov 15;61(10):1566-72. doi: 10.1093/cid/civ554. Epub 2015 Jul 8.
Results Reference
derived
PubMed Identifier
25668820
Citation
Lipshultz HM, Hileman CO, Ahuja S, Funderburg NT, McComsey GA. Anaemia is associated with monocyte activation in HIV-infected adults on antiretroviral therapy. Antivir Ther. 2015;20(5):521-7. doi: 10.3851/IMP2940. Epub 2015 Feb 10.
Results Reference
derived
PubMed Identifier
25514794
Citation
Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
Results Reference
derived
PubMed Identifier
25015912
Citation
Longenecker CT, Hileman CO, Funderburg NT, McComsey GA. Rosuvastatin preserves renal function and lowers cystatin C in HIV-infected subjects on antiretroviral therapy: the SATURN-HIV trial. Clin Infect Dis. 2014 Oct 15;59(8):1148-56. doi: 10.1093/cid/ciu523. Epub 2014 Jul 11.
Results Reference
derived
PubMed Identifier
24691204
Citation
Longenecker CT, Jiang Y, Orringer CE, Gilkeson RC, Debanne S, Funderburg NT, Lederman MM, Storer N, Labbato DE, McComsey GA. Soluble CD14 is independently associated with coronary calcification and extent of subclinical vascular disease in treated HIV infection. AIDS. 2014 Apr 24;28(7):969-77. doi: 10.1097/QAD.0000000000000158.
Results Reference
derived
PubMed Identifier
24253250
Citation
Funderburg NT, Jiang Y, Debanne SM, Storer N, Labbato D, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin treatment reduces markers of monocyte activation in HIV-infected subjects on antiretroviral therapy. Clin Infect Dis. 2014 Feb;58(4):588-95. doi: 10.1093/cid/cit748. Epub 2013 Nov 18.
Results Reference
derived
PubMed Identifier
23332012
Citation
Longenecker CT, Funderburg NT, Jiang Y, Debanne S, Storer N, Labbato DE, Lederman MM, McComsey GA. Markers of inflammation and CD8 T-cell activation, but not monocyte activation, are associated with subclinical carotid artery disease in HIV-infected individuals. HIV Med. 2013 Jul;14(6):385-90. doi: 10.1111/hiv.12013. Epub 2013 Jan 18.
Results Reference
derived
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Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
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