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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections HIV-Associated Lipodystrophy Syndrome | Drug: Lopinavir/ritonavir + zidovudine + lamivudine Drug: Lopinavir/ritonavir + nevirapine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) |
Study Start Date : | January 2003 |
Study Completion Date : | July 2008 |
- 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)
- 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)

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122226
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland | |
Netherlands | |
Academic Medical Center | |
Amsterdam, Netherlands | |
Medisch Centrum Jan van Goyen | |
Amsterdam, Netherlands | |
Onze Lieve Vrouwe Gasthuis, location Oosterpark | |
Amsterdam, Netherlands | |
Onze Lieve Vrouwe Gasthuis, location Prinsengracht | |
Amsterdam, Netherlands | |
Slotervaart ziekenhuis | |
Amsterdam, Netherlands | |
VUMC Free University Medical Center | |
Amsterdam, Netherlands | |
Ziekenhuis Leyenburg | |
den Haag, Netherlands | |
Kennemer Gasthuis, location Elisabeth | |
Haarlem, Netherlands | |
Leids Universitair Medisch Centrum | |
Leiden, Netherlands | |
Erasmus Universitair Medisch Centrum | |
Rotterdam, Netherlands | |
Spain | |
Hospital Clinic | |
Barcelona, Spain | |
United Kingdom | |
Royal Free Hospital | |
London, United Kingdom |
Principal Investigator: | S. A. Danner, MD, PhD | Free University Medical Center | |
Principal Investigator: | P. Reiss, MD, PhD | Academic Medical Center, National AIDS Therapy Evaluation Centre |
ClinicalTrials.gov Identifier: | NCT00122226 |
Other Study ID Numbers: |
protocol 02-72 |
First Posted: | July 21, 2005 Key Record Dates |
Last Update Posted: | April 25, 2006 |
Last Verified: | July 2005 |
HIV HIV-associated lipodystrophy syndrome |
HIV-Associated Lipodystrophy Syndrome Lipodystrophy HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Skin Diseases, Metabolic |
Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Ritonavir Lopinavir Lamivudine Zidovudine Nevirapine HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |