Mechanisms of Lipodystrophy in HIV-Infected Pateints
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|ClinicalTrials.gov Identifier: NCT00457665|
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : June 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Viracept versus Sustiva with stavudine and epivir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mecahnisms of Lipodystrophy in HIV-Infected Patients|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2014|
- 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.
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): 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|