Human immunodeficiency virus [HIV] disease resulting in other conditions
Conditions
Interventions
The experimental arm A : 50 subjects take orally one tablet of Atorvastatin 10-20 mg + 1 tablet of oral acetylsalicylic acid 100 mg 1 time daily for 24 weeks.
Trial arm B: 50 subjects take orally 1 t
Drug
Sponsors
Hospital das Clínicas da Universidade Federal de Pernambuco
Hospital das Clínicas da Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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 .
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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 • Occurrence of adverse events, including epigastric pain and / or muscle pain, fatigue, transaminase elevation and Creatine phosphokinase in monthly medical visits. • 25% reduction in the levels of triglycerides , total cholesterol and fractions at weeks 0 , 12 and 24 observed in biochemical tests of peripheral blood. | — |
Countries
Brazil
Contacts
Public ContactHeloísa Lacerda
Universidade Federal de Pernambuco
Outcome results
None listed