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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097108
• Other study ID #: AGMT_HIV1
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2014
• Last updated: May 25, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir

Locations

Country	Name	City	State
Austria	PMU Salzburg	Salzburg
Austria	AKH Wien	Wien
Austria	Ottto Wagner Spital	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the plasma concentration of cholesterol	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.	12 weeks	No
Secondary	changes from baseline in total cholesterol, triglycerides and HDL cholesterol over time		24 weeks	No
Secondary	evaluate risk reduction of cardiovascular risk during the treatment period according to Framingham risk score		24 weeks	No