HIV Seropositivity Clinical Trial
Official title:
Multicenter, Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
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.
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