Back to resultsChanges in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Raltegravir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV infection, Raltegravir, Switch, Hyperlipidemia, Women
Eligibility Criteria
Inclusion Criteria:
- Documented HIV-1 infection in female patients, age ≥18 years
- Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
- Plasma HIV viral load <50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
- Fasting LDL cholesterol >130 mg/dl
- Fasting triglycerides <450 mg/dl
Exclusion Criteria:
- History of virological failure during previous antiretroviral therapy
Sites / Locations
- PMU Salzburg
- AKH Wien
- Ottto Wagner Spital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Raltegravir
Arm Description
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.
Outcomes
Primary Outcome Measures
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
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.
Secondary Outcome Measures
Total Cholesterol Baseline and After 24 Weeks
Triglycerides Baseline and After 24 Weeks
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
Full Information
NCT ID
NCT02097108
First Posted
March 24, 2014
Last Updated
July 26, 2016
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02097108
Brief Title
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV infection, Raltegravir, Switch, Hyperlipidemia, Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raltegravir
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Primary Outcome Measure Information:
Title
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
Description
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.
Time Frame
baseline to week 12
Secondary Outcome Measure Information:
Title
Total Cholesterol Baseline and After 24 Weeks
Time Frame
baseline to week 24
Title
Triglycerides Baseline and After 24 Weeks
Time Frame
baseline to week 24
Title
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
Time Frame
baseline to week 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented HIV-1 infection in female patients, age ≥18 years
Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
Plasma HIV viral load <50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
Fasting LDL cholesterol >130 mg/dl
Fasting triglycerides <450 mg/dl
Exclusion Criteria:
History of virological failure during previous antiretroviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Greil, MD
Organizational Affiliation
PMU Salzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Ottto Wagner Spital
City
Wien
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
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