Mechanisms of Lipodystrophy in HIV-Infected Pateints

HIV Infections Clinical Trial

Official title: Mecahnisms of Lipodystrophy in HIV-Infected Patients

Status Completed

Clinical Trial Summary

The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

Clinical Trial Description

A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy. ;

Related Conditions & MeSH terms

• HIV Infections
• Lipodystrophy

• NCT number: NCT00457665
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: February 2002
• Completion date: October 2014