Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.
This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||One Arm, Open Label, Interventional, Non-comparative Study to Assess Changes in Lipids and Lipoproteins in HIV Infected Women With Hyperlipidemia After Switch From Boosted Protease Inhibitor to Raltegravir|
- Reduction in the plasma concentration of cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.
- changes from baseline in total cholesterol, triglycerides and HDL cholesterol over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- evaluate risk reduction of cardiovascular risk during the treatment period according to Framingham risk score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Study Completion Date:||May 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097108
|Salzburg, Austria, 5020|
|Wien, Austria, 1090|
|Ottto Wagner Spital|
|Wien, Austria, 1140|
|Principal Investigator:||Richard Greil, MD||PMU Salzburg|