Mechanisms of Lipodystrophy in HIV-Infected Pateints

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457665
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : June 1, 2015
Bristol-Myers Squibb
Information provided by:
University of Texas Southwestern Medical Center

April 4, 2007
April 6, 2007
June 1, 2015
February 2002
October 2007   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00457665 on Archive Site
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.
Same as current
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Mechanisms of Lipodystrophy in HIV-Infected Pateints
Mecahnisms of Lipodystrophy in HIV-Infected Patients

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.

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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Viracept versus Sustiva with stavudine and epivir
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2014
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV Positive
  • No previous antiviral therapy
  • 18 to 70 years of age

Exclusion Criteria:

  • Patients with opportunistic infections or AIDS.
  • Active intravenous drug users.
  • Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.
  • Patients with diabetes mellitus.
  • Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).
  • Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).
  • Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.
  • Anemia (hematocrit <32%).
  • Abnormal thyroid function tests.
  • Weight loss >10% from baseline in the past year.
  • Recent (within the past year), history of suicide attempt.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Texas Southwestern Medical Center
  • Bristol-Myers Squibb
  • GlaxoSmithKline
Principal Investigator: Abhimanyu Garg, M.D. University of Texas Southwestern Medical Center Dallas
University of Texas Southwestern Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP