Phase 2 Completed N=147 Randomized Triple-blind Prevention

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

HIV · Heart Failure

Source: ClinicalTrials.gov NCT01218802 ↗

Enrolled (actual)

147

Serious AEs

0.7%

Results posted

Mar 2016

Primary outcomePrimary: Bone Mineral Density (BMD) — -0.03; -0.53 percentage of change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Mineral Density (BMD)	-0.03; -0.53	—
PRIMARY Carotid IMT	1.21; 4.04	—

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 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 3 X ULN
Calculated creatinine clearance < 50 mL/min

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01218802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.