A study to evaluate the effect of changing HIV medication (from a protease inhibitor or efavirenz to raltegravir) on liver fat, fat tissue and metabolic parameters (blood sugar and cholesterol, etc) in overweight or obese patients with metabolic problems.
- Conditions
- Study subjects are HIV infected patients with BMI>25kg/m2 and who have at least one metabolic syndrome component or a fatty liver disease.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2017-003430-85-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
•Written informed consent (IC) obtained
•HIV-positive adult (over 18 years) 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 VL < 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 VL < 50 cop/ml measurements conducted during the past 12 months prior to inclusion: one within 6 months prior to screening
•HIV VL < 50 cop/ml at screening
•BMI>25 kg/m2 and at least one metabolic syndrome condition, which are
o BP = 130/= 85 mmHg or hypertension medication currently in use or
ofasting glucose = 5.6 mmol/l or B-HbA1C > 42 mmol/mol or diabetes medication currently in use or
oHDL < 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
owaist 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
•Within 12 month window period prior to screening, one or more HIV VL measurement of >50 cop/ml
•More than one consecutive HIV VL 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method