Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
|ClinicalTrials.gov Identifier: NCT02097108|
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : September 13, 2016
Last Update Posted : September 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
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.
- Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction [ Time Frame: baseline to week 12 ]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 ]
- Triglycerides Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ]
- High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097108
|Salzburg, Austria, 5020|
|Wien, Austria, 1090|
|Ottto Wagner Spital|
|Wien, Austria, 1140|
|Principal Investigator:||Richard Greil, MD||PMU Salzburg|