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Mechanisms of Lipodystrophy in HIV-Infected Pateints

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
GlaxoSmithKline
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00457665
First received: April 4, 2007
Last updated: June 19, 2008
Last verified: June 2008

April 4, 2007
June 19, 2008
February 2002
Not Provided
  • 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Viracept versus Sustiva with stavudine and epivir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2007
Not Provided

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00457665
R01-56583
Yes
Not Provided
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
June 2008

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