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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00122226 |
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Date of registration:
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14/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
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Scientific title:
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MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00122226 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Finland
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Netherlands
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Spain
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United Kingdom
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Contacts
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Name:
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P. Reiss, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Center, National AIDS Therapy Evaluation Centre |
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Name:
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S. A. Danner, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Free University Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV Infections
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HIV-Associated Lipodystrophy Syndrome
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Intervention(s)
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Drug: Lopinavir/ritonavir + nevirapine
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Drug: Lopinavir/ritonavir + zidovudine + lamivudine
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Primary Outcome(s)
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insulin resistance (3, 12, 24, 36 months)
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macrovascular function (12, 24, 36 months)
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body composition (3, 12, 24, 36 months)
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lipid profile (3, 12, 24, 36 months)
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microvascular function (3, 12, 24, 36 months)
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Secondary Outcome(s)
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mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
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gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
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natural killer cells (3, 12, 24 months)
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bone mineral density (12, 24, 36 months)
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Secondary ID(s)
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protocol 02-72
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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