Mechanisms of Lipodystrophy in HIV-Infected Pateints
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.
Drug: Viracept versus Sustiva with stavudine and epivir
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Mecahnisms of Lipodystrophy in HIV-Infected Patients|
- Effect of drug regimens on adiposity overall and regional at year one and year two as compared to baseline
- Effect of drug regimens on plasma glucose and insulin during OGTT at year one and two as compared with baseline
- Effect of drug regimens on serum triglycerides and HDL cholesterol at year one and two as compared with baseline
- Multiple regression models will also be constructed to assess which factors in addition to PI therapy explain the variability in body fat changes, serum glucose, insulin and lipoproteins.
|Study Start Date:||February 2002|
|Study Completion Date:||March 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457665
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Abhimanyu Garg, M.D.||University of Texas Southwestern Medical Center Dallas|