Phase 4
N=45
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
HIV Seropositivity · Metabolic Syndrome · Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT03374358 ↗Enrolled (actual)
45
Serious AEs
2.3%
Results posted
Jul 2021
Primary outcome: Primary: Change in Liver Fat — 0.3; 0.6 % hepatic fat fraction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Raltegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Liver Fat |
0.3; 0.6 | — |
| SECONDARY Change in Subcutaneous and Visceral Adipose Tissue Volume |
-74; 242; 100; 66 | — |
| SECONDARY Change in Body Weight and Total Body Fat |
0.9; 2.0; -0.3; 1.5 | — |
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.
Eligibility Criteria
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 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 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 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.
Data sourced from ClinicalTrials.gov (NCT03374358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.