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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT02097108
First received: March 24, 2014
Last updated: April 3, 2014
Last verified: April 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Reduction in the plasma concentration of cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • changes from baseline in total cholesterol, triglycerides and HDL cholesterol over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • evaluate risk reduction of cardiovascular risk during the treatment period according to Framingham risk score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Ages Eligible for Study:   18 Years and older
Genders 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
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 Not yet recruiting
Salzburg, Austria, 5020
Contact: Ninon Taylor, MD       n.taylor@salk.at   
Principal Investigator: Richard Greil, MD         
AKH Wien Not yet recruiting
Wien, Austria, 1090
Contact: Armin Rieger, MD       armin.rieger@meduniwien.ac.at   
Principal Investigator: Armin Rieger, MD         
Ottto Wagner Spital Not yet recruiting
Wien, Austria, 1140
Contact: Brigitte Schmied, MD       brigitte.schmied@wienkav.at   
Principal Investigator: Brigitte Schmied, MD         
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Richard Greil, MD PMU Salzburg
  More Information

No publications provided

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: April 3, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
HIV infection
Raltegravir
Switch
Hyperlipidemia
Women

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Anti-HIV Agents
Hyperlipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014