Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier
NCT02097108

First received: March 24, 2014
Last updated: July 26, 2016
Last Verified: July 2016
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : Raltegravir
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: May 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: 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.
Drug: Raltegravir
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097108

Locations

Austria
PMU Salzburg
Salzburg, Austria, 5020
AKH Wien
Wien, Austria, 1090
Ottto Wagner Spital
Wien, Austria, 1140

Sponsors and Collaborators

Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme Corp.

Investigators

Principal Investigator: Richard Greil, MD PMU Salzburg
More Information

More Information


Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie  
ClinicalTrials.gov Identifier: NCT02097108   History of Changes  
Other Study ID Numbers: AGMT_HIV1  
Study First Received: March 24, 2014  
Last Updated: July 26, 2016  

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

HIV infection
Raltegravir
Switch
Hyperlipidemia
Women

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this data on April 08, 2020
This information is provided by ClinicalTrials.gov.