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

Condition	Intervention	Phase
HIV Infections HIV-Associated Lipodystrophy Syndrome	Drug: Lopinavir/ritonavir + zidovudine + lamivudine  Drug: Lopinavir/ritonavir + nevirapine	Phase IV

Further Study Details: 

Primary Outcomes: insulin resistance (3, 24, 36 months); microvascular function (3, 24, 36 months); lipid profile (3, 24, 36 months); body composition (3, 24, 36 months); macrovascular function (24, 36 months)
Secondary Outcomes: mitochondrial DNA in PBMC and fatty tissue (24, 36 months); apoptosis, gene expression fatty tissue (24, 36 months); bone mineral density (24, 36 months); natural killer cells (3, 12, 24 months)
Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Male

Criteria

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.

Finland
      Helsinki University Central Hospital, Helsinki,  Finland
Netherlands
      VUMC Free University Medical Center, Amsterdam,  Netherlands
      Academic Medical Center, Amsterdam,  Netherlands
      Onze Lieve Vrouwe Gasthuis, location Oosterpark, Amsterdam,  Netherlands
      Onze Lieve Vrouwe Gasthuis, location Prinsengracht, Amsterdam,  Netherlands
      Slotervaart ziekenhuis, Amsterdam,  Netherlands
      Medisch Centrum Jan van Goyen, Amsterdam,  Netherlands
      Kennemer Gasthuis, location Elisabeth, Haarlem,  Netherlands
      Leids Universitair Medisch Centrum, Leiden,  Netherlands
      Erasmus Universitair Medisch Centrum, Rotterdam,  Netherlands
      Ziekenhuis Leyenburg, Den Haag,  Netherlands
Spain
      Hospital Clinic, Barcelona,  Spain
United Kingdom
      Royal Free Hospital, London,  United Kingdom

Study chairs or principal investigators

S. A. Danner, MD, PhD,  Principal Investigator,  Free University Medical Center   
P. Reiss, MD, PhD,  Principal Investigator,  Academic Medical Center, National AIDS Therapy Evaluation Centre   

Study ID Numbers:  protocol 02-72
Last Updated:  July 25, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00122226
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23