The effect of atorvastatin plus aspirin compared with a non-therapeutic substance on the function of the blood vessels and inflammation in HIV patients under treatment presenting a low risk of cardiovascular disease.
- Conditions
- Human immunodeficiency virus [HIV] disease resulting in other conditions
- Registration Number
- RBR-39bjm4
- Lead Sponsor
- Hospital das Clínicas da Universidade Federal de Pernambuco
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
HIV patients on antiretroviral use ; both genders , aged between 18 and 60; lower cardiovascular risk than 10 % probability of occurrence of cardiovascular events in 10 years , as measured by the Framingham risk score .
history of hospitalization and opportunistic infections in the past 90 days; history of chronic liver dysfunction, thyroid dysfunction, autoimmune disease, history of hepatitis B or C; pregnancy or breastfeeding; previous use of statins, fibrates, ezetemibe, omega 3 , aspirin, NSAIDs, oral anticoagulants, interferon, interleukins, growth hormones, immunoglobulins, glucocorticoids or other immunosuppressants; alcohol abuse; previous intolerance to statins and aspirin; hemophilia; AST and ALT greater or equal 120 IU / L; CPK grater ou equal 167 U / L; muscle trauma or recent surgery performed until four months earlier; history of cardiovascular disease, diabetes, cancer and renal dysfunction.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference by 10% or more in diameter of the brachial artery at rest and after stimulation with redness , measured at time zero , after 3 months and 6 months in Doppler ultrasound device .
- Secondary Outcome Measures
Name Time Method • Reduced levels of inflammatory mediators by 25% (IFN-gama, IL-1, IL-6, IL-10, MCP-1, NT-PROBNP, TNF-alfa, VEGF e PCR) in peripheral blood in week 0, 12 and 24 <br>• Occurrence of adverse events, including epigastric pain and / or muscle pain, fatigue, transaminase elevation and Creatine phosphokinase in monthly medical visits.<br>• 25% reduction in the levels of triglycerides , total cholesterol and fractions at weeks 0 , 12 and 24 observed in biochemical tests of peripheral blood.