Status:
COMPLETED
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Seropositivity
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- fasting glucose ≥ 5.6 mmol/l or B-HbA1C \> 42 mmol/mol or diabetes medication currently in use or
- HDL \< 1.0 mmol/l in men and \< 1.3 mmol/l in women or triglycerides ≥ 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
- waist circumference \> 94 cm in men and \>80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation). OR
- ultrasound or biopsy proven hepatosteatosis.
Exclusion
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03374358
Start Date
January 10 2018
End Date
November 30 2019
Last Update
September 5 2021
Active Locations (1)
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1
Aurora hospital, Department of Infectious Diseases
Helsinki, Finland