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

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Viracept versus Sustiva with stavudine and epivir Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Stavudine

Primary Outcome Measures :
  1. Effect of drug regimens on adiposity overall and regional at year one and year two as compared to baseline
  2. Effect of drug regimens on plasma glucose and insulin during OGTT at year one and two as compared with baseline
  3. Effect of drug regimens on serum triglycerides and HDL cholesterol at year one and two as compared with baseline

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00457665

United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Bristol-Myers Squibb
Principal Investigator: Abhimanyu Garg, M.D. University of Texas Southwestern Medical Center Dallas Identifier: NCT00457665     History of Changes
Other Study ID Numbers: R01-56583
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: August 2014

Keywords provided by University of Texas Southwestern Medical Center:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents