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

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Heart Disease; HIV Infections

Treatments: Drug: Placebo; Drug: Rosuvastatin 10 mg. daily for 96 weeks

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01218802

1R01NR012642-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

147 participants in 2 patient groups, including a placebo group

Rosuvastatin

Active Comparator group

Description:

Participants will take Rosuvastatin 10 mg. daily for 96 weeks

Treatment:

Drug: Rosuvastatin 10 mg. daily for 96 weeks

Sugar Pill placebo

Placebo Comparator group

Description:

Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.

Treatment:

Drug: Placebo