MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

HIV Infections Clinical Trial

Official title:

MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00122226
• Other study ID #: protocol 02-72
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 14, 2005
• Last updated: April 24, 2006
• Start date: January 2003
• Est. completion date: July 2008

Study information

• Verified date: July 2005
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• Lopinavir/ritonavir + zidovudine + lamivudine

• Lopinavir/ritonavir + nevirapine

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
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
Spain	Hospital Clinic	Barcelona
United Kingdom	Royal Free Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
VU University Medical Center	Abbott, Boehringer Ingelheim

Countries where clinical trial is conducted

Finland,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance (3, 12, 24, 36 months)
Primary	microvascular function (3, 12, 24, 36 months)
Primary	lipid profile (3, 12, 24, 36 months)
Primary	body composition (3, 12, 24, 36 months)
Primary	macrovascular function (12, 24, 36 months)
Secondary	mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
Secondary	gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
Secondary	bone mineral density (12, 24, 36 months)
Secondary	natural killer cells (3, 12, 24 months)