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|
- Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction [ Time Frame: baseline to week 12 ] [ 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.
- Total Cholesterol Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
- Triglycerides Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
- High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (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|