Effect of switching efavirenz to rilpivirine in treatment of HIV- infected patients with dyslipidemia
- Conditions
- HIV and dyslipidemia
- Registration Number
- TCTR20141019001
- Lead Sponsor
- Infectious disease association of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria:
-HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
-plasma HIV RNA<50 cp/ml during the previous 6 months
-Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >130 mg/dL in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD,DM
-Low-Density Lipoprotein cholesterol (LDL-c)>160 mg/dL regardless of CHD risk factors.
-Diagnosed dyslipidemia and current treatment with lipid lowering agent
-Receive ongoing therapy with proton pump inhibitor, rifamycin, carbamazepine, oxcarbamazepine, phenobarbital, phenytoin,systemic steroid and St John’s wort
-Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >3N
-Pregnancy
-Severe depression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in LDL cholesterol between baseline and week 24 at 6 months after end of the intervention Measure LDL cholesterol level
- Secondary Outcome Measures
Name Time Method Viral suppression and Depression at 6 months after end of the intervention Thai Depresssive Inventory score