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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02097108
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Total Cholesterol Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ]
  2. Triglycerides Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ]
  3. High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks [ Time Frame: baseline to week 24 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02097108

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.
Principal Investigator: Richard Greil, MD PMU Salzburg

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT02097108     History of Changes
Other Study ID Numbers: AGMT_HIV1
First Posted: March 26, 2014    Key Record Dates
Results First Posted: September 13, 2016
Last Update Posted: September 13, 2016
Last Verified: July 2016

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
HIV infection

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Raltegravir Potassium
Protease Inhibitors
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action