Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks

HIV Infections Clinical Trial

Official title:

Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218802
• Other study ID #: 1R01NR012642-01
• 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

• Heart Disease
• Heart Diseases
• HIV Infections

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