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Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir | Clinical Trials | Clareo Health

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Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir

Effect on Liver Fat, Adipose Tissue and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Once Daily Raltegravir in HIV+ Patients With Body Mass Index Over 25 kg/m2 and With at Least One Metabolic Syndrome Component

NCT03374358•Helsinki University Central Hospital

View on ClinicalTrials.gov

Summary

This study will provide data on the switch from a protease inhibitor or efavirenz to the new formulation of raltegravir (RAL) dosed once daily. The study group consists of patients with metabolic risk factors and co-morbidities, in need of optimization of their current ART to minimize the drug-related metabolic side effects as standard of care. The primary objective of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir once daily reduces liver fat in patients who are overweight or obese and have at least one metabolic syndrome component. For this purpose, the liver fat content will be analyzed using the proton magnetic resonance spectroscopy. In addition, the aim is to clarify the change in the body composition and metabolism in this study group. For this purpose the visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) volumes will be measured and subcutaneous tissue samples will be collected for future analyses of adipose tissue function.

Detailed Description

The prevalences of overweight (body-mass-index, BMI 25-30 kg/m2) and obesity (BMI\>30 kg/m2) are steadily increasing among HIV-infected patients globally. In parallel, the risk of non-alcoholic fatty liver disease (NAFLD) increases. Clinically alarming are the data which suggest that HIV infected have higher rates of progressive form of NAFLD than non-HIV infected age, gender and BMI matched controls. As the treatment for HIV is life-long, it is crucial to understand the effects of different antiretroviral therapy (ART) regimens on metabolism. Some antiretroviral agents appear to promote unfavourable changes in metabolism (e.g. in blood lipids) and predispose to trunk fat redistribution and liver fat accumulation. Raltegravir has been demonstrated to have beneficial impact on some metabolic parameters compared to the protease inhibitor class or efavirenz. In this study, the aim is to investigate whether switching a protease inhibitor or efavirenz to raltegravir reduces liver fat in patients who are overweight or obese and have at least one metabolic syndrome component. For this purpose, the proton magnetic resonance spectroscopy will be used. In addition, the aim is to clarify the change in the body composition in this study group. For this purpose, the visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) volumes will be measured using MRI. To acquire more knowledge on metabolic effects in adipose tissue level, subcutaneous adipose tissue biopsies will be collected together with blood, saliva and feces samples.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent (IC) obtained.
•HIV-positive adult (age over 18) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months.
•Current ART includes either a protease inhibitor or efavirenz.
•No documented or suspected resistance to integrase inhibitors or to NRTIs.
•No prior history of virologic failure. Failure is defined as a confirmed plasma viral load \> 200 cop/ml measured no less than six months after initiation or modification of therapy.
•Virological blips accepted only if a single viral load measurement has been between 50-200 cop/ml followed by viral load \< 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening.
•Documented evidence of at least two HIV viral load \< 50 cop/ml measurements during the past 12 months prior to inclusion: one within 6 months prior to screening.
•HIV viral load \< 50 cop/ml at screening.
•BMI\>25 kg/m2 and one metabolic syndrome condition, which are
•* BP ≥ 130/≥ 85 mmHg or hypertension medication currently in use or
+4 more criteria

Exclusion Criteria

•Within 12 month window period prior to screening, HIV viral load measurement of \>50 cop/ml.
•More than one consecutive HIV viral load measurements of \> 50 cop/ml in the treatment history after initial viral suppression with ART.
•Chronic hepatitis B or C.
•Daily alcohol consumption ≥ 30 g for men and ≥ 20 g for women.
•Pregnancy or planned pregnancy during the study period.
•Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start.
•Psychiatric disorder, which prevents a study subject to understand the study protocol.
•Other serious disease, which prevents a study subject to participate in the study.
•For MRI/spectroscopy imaging: metal objects in the body or claustrophobia.

Locations (1)

Aurora hospital, Department of Infectious Diseases

Helsinki, Finland

Key Dates

Start Date

January 10, 2018

Primary Completion Date

November 2, 2019

Completion Date

November 30, 2019

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

HIV SeropositivityMetabolic SyndromeFatty Liver

Interventions

Raltegravir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

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