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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01218802
Other study ID # 1R01NR012642-01
Secondary ID
Status Completed
Phase Phase 2
First received October 8, 2010
Last updated March 3, 2016
Start date February 2011
Est. completion date May 2014

Study information

Verified date March 2016
Source University Hospital Case Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Rosuvastatin 10 mg. daily for 96 weeks
Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
Placebo
participants will take a sugar pill daily for 96 weeks

Locations

Country Name City State
United States University Hospitals of Cleveland Case Medical Center Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Case Medical Center AstraZeneca, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone Mineral Density (BMD) Measured by change in bone DEXA from baseline to week 96 96 weeks No
Primary Carotid IMT changes in carotid IMT is a good measure for cardiovascular disease progression 96 weeks No
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