HIV-Associated Lipodystrophy Syndrome, HIV Infections
Conditions
Keywords
HIV, HIV-associated lipodystrophy syndrome
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.
Interventions
DRUGLopinavir/ritonavir + zidovudine + lamivudine
DRUGLopinavir/ritonavir + nevirapine
Sponsors
Abbott
Boehringer Ingelheim
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male * Age between 18 and 70 years. * No prior use of antiretroviral therapy * Indication for antiretroviral treatment according to common standards
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| macrovascular function (12, 24, 36 months) | — |
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months) | — |
Countries
Finland, Netherlands, Spain, United Kingdom
Outcome results
None listed