MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
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ClinicalTrials.gov Identifier: NCT00122226 |
Recruitment Status : Unknown
Verified July 2005 by Amsterdam UMC, location VUmc.
Recruitment status was: Active, not recruiting
First Posted : July 21, 2005
Last Update Posted : April 25, 2006
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Sponsor:
Amsterdam UMC, location VUmc
Collaborators:
Abbott
Boehringer Ingelheim
Information provided by:
Amsterdam UMC, location VUmc
Tracking Information | |||||||
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First Submitted Date ICMJE | July 14, 2005 | ||||||
First Posted Date ICMJE | July 21, 2005 | ||||||
Last Update Posted Date | April 25, 2006 | ||||||
Study Start Date ICMJE | January 2003 | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) | ||||||
Official Title ICMJE | MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) | ||||||
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 Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Enrollment ICMJE |
50 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date ICMJE | July 2008 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Finland, Netherlands, Spain, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00122226 | ||||||
Other Study ID Numbers ICMJE | protocol 02-72 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Not Provided | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Amsterdam UMC, location VUmc | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Amsterdam UMC, location VUmc | ||||||
Verification Date | July 2005 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |