MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
- Conditions
- HIV InfectionsHIV-Associated Lipodystrophy Syndrome
- Registration Number
- NCT00122226
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.
- Detailed Description
This is a randomized prospective study into metabolic adverse events during initial antiretroviral therapy in HIV-1-infected men. The following regimens are compared: lopinavir-ritonavir + Combivir and lopinavir-ritonavir + nevirapine (nucleoside reverse transcriptase inhibitor \[NRTI\]-sparing). Prior to the start of therapy and 3, 12, 24, and 36 months thereafter the distribution of body fat and bone density (bioelectrical impedance analysis \[BIA\], computed tomography \[CT\] and dual energy x-ray absorptiometry \[DEXA\]), lipid spectrum, mitochondrial DNA (peripheral blood mononuclear cells \[PBMCs\] and adipose tissue biopsies) and vascular measurements are performed. In addition, insulin sensitivity is measured in a subgroup of sixteen individuals by using a hyperinsulinemic euglycemic clamp and performing microvascular measurements. The aim of the study is to obtain prospective insight into the occurrence of various aspects of metabolic adverse events on the one hand and to compare an NRTI-containing therapy with an NRTI-sparing therapy on the other hand. The hypothesis is that in the NRTI-sparing arm, less metabolic and vascular changes are observed than in the NRTI containing regimen.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 50
- Male
- Age between 18 and 70 years.
- No prior use of antiretroviral therapy
- Indication for antiretroviral treatment according to common standards
- Female sex
- Body mass index (kg/m2) > 35.
- Known history of diabetes mellitus or hyperlipidemia
- Use of coenzyme A reductase inhibitor or fibric acid derivative in the last 6 weeks before inclusion
- Use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates
- Use of nandrolone or testosterone
- Any disorder or condition which can be expected to lead to lessened compliance with the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method insulin resistance (3, 12, 24, 36 months) microvascular function (3, 12, 24, 36 months) lipid profile (3, 12, 24, 36 months) body composition (3, 12, 24, 36 months) macrovascular function (12, 24, 36 months)
- Secondary Outcome Measures
Name Time Method mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months) gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months) bone mineral density (12, 24, 36 months) natural killer cells (3, 12, 24 months)
Trial Locations
- Locations (13)
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Oosterpark
🇳🇱Amsterdam, Netherlands
Ziekenhuis Leyenburg
🇳🇱den Haag, Netherlands
Royal Free Hospital
🇬🇧London, United Kingdom
Medisch Centrum Jan van Goyen
🇳🇱Amsterdam, Netherlands
Erasmus Universitair Medisch Centrum
🇳🇱Rotterdam, Netherlands
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Onze Lieve Vrouwe Gasthuis, location Prinsengracht
🇳🇱Amsterdam, Netherlands
Slotervaart ziekenhuis
🇳🇱Amsterdam, Netherlands
VUMC Free University Medical Center
🇳🇱Amsterdam, Netherlands
Kennemer Gasthuis, location Elisabeth
🇳🇱Haarlem, Netherlands
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Hospital Clinic
🇪🇸Barcelona, Spain