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Completed

NCT Number: NCT02097108

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

PMU Salzburg, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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