Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir

• Registration Number: NCT02097108
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Study Start: 2014-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-06-15
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Results First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Raltegravir	Raltegravir	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.

Primary Outcome Measures

Name	Time	Method
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction	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.

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol Baseline and After 24 Weeks	baseline to week 24
Triglycerides Baseline and After 24 Weeks	baseline to week 24
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks	baseline to week 24

Trial Locations

Locations (3)

AKH Wien; 🇦🇹 Wien, Austria

PMU Salzburg; 🇦🇹 Salzburg, Austria

Ottto Wagner Spital; 🇦🇹 Wien, Austria