Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center (SPARC)
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Multicenter, Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo|
- change in inflammatory markers - hsCRP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]To assess change in hsCRP after 24 weeks of therapy with rosuvastatin
- effect of rosuvastatin on pulmonary and cardiac status by use of cIMT/FMD/ Vascular studies are a measure of preclinical atherosclerosis and predicts future cardiovascular events and mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]noninvsive Vascular cIMT, FMD and Glycocalyx will be measured at the beginning and at the end of the study
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
manufactured sugar pill to mimic rouvastatin once a day for 24 weeks
suger pill manufactured to mimic crestor pills
Experimental: Rouvastatin calcium
Rouvastatin calcium once a day by mouth for 24 weeks.
Drug: Rouvastatin calcium
Other Name: Crestor
Growing evidence indicates that chronic obstructive pulmonary disease (COPD) is an important cause of respiratory impairment in HIV+ persons and will likely increase as the HIV+ population continues to age. In the HIV-uninfected population, COPD frequently co-exists with cardiac disease including atherosclerosis and pulmonary hypertension (PH). The investigators work has demonstrated that a syndrome of "cardiopulmonary dysfunction" exists even in non-smoking or antiretroviral-treated HIV+ individuals. The investigators have found that HIV+ individuals have a high prevalence of respiratory symptoms, airflow obstruction, and diffusing capacity (DLco) abnormalities that occur concurrently with cardiac co-morbidities, including radiographic measures of atherosclerosis and elevated echocardiographic pulmonary artery pressures. This syndrome is marked by inflammation with elevated levels of cytokines and hsCRP, peripheral T-cell activation, and increased sputum neutrophils as well as elevation of NT-proBNP, a marker of heart strain. Importantly, the investigators have shown that DLco impairment and elevated NT-proBNP are significant independent predictors of mortality in HIV, indicating that cardiopulmonary dysfunction is likely highly clinically relevant and identifies a vulnerable population in whom the investigators lack effective interventions.
Statins have anti-inflammatory effects in the lung and vasculature that might benefit cardiopulmonary dysfunction in HIV. These agents have a long history of clinical use in cardiovascular disease and are currently being investigated as disease-modifying drugs for HIV, COPD, and PH. In preliminary analyses, the investigators have found that HIV+ individuals who received statin therapy within the past year were significantly less likely to have impaired DLco and had lower pulmonary artery pressures, lower NT-proBNP, lower peripheral cytokines, and fewer sputum neutrophils despite being older and having a greater smoking history than those not using statins.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881971
|United States, California|
|University of California, Los Angelos|
|Los Angelos, California, United States, 90095|
|University of California, SF|
|San Francisco, California, United States, 94118|
|United States, Pennsylvania|
|University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Alison M Morris, MD, MS||University of Pittsburgh|