Clinical Trial: Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicenter, Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo

Brief Summary: Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.

Detailed Summary:

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 pe
Sponsor: University of Pittsburgh

Current Primary Outcome: change in inflammatory markers - hsCRP [ Time Frame: 24 weeks ]

To assess change in hsCRP after 24 weeks of therapy with rosuvastatin


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

noninvsive Vascular cIMT, FMD and Glycocalyx will be measured at the beginning and at the end of the study


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: April 2, 2013
Date Started: May 2013
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016