Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122226
Status:
UNKNOWN
Last Update Posted:
2006-04-25
First Post:
2005-07-14
Brief Title:
MEDICLAS Study Metabolic Effects of Different Classes of AntiretroviralS
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
MEDICLAS Study Metabolic Effects of Different Classes of AntiretroviralS
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None