Clinical Trials


Mechanisms of Lipodystrophy in HIV-Infected Pateints

This study has been completed
University of Texas Southwestern Medical Center

Bristol-Myers Squibb

Information provided by (Responsible Party)
University of Texas Southwestern Medical Center Identifier

First received: April 4, 2007
Last updated: May 8, 2019
Last Verified: May 2019
History of Changes


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 Intervention Phase
HIV Infections

Drug : Nelfinavir
Drug : Efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mecahnisms of Lipodystrophy in HIV-Infected Patients

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures

  • Effect of Drug Regimens on Serum Triglycerides. [ Time Frame: 12 and 24 months ]

Enrollment: 56
Study Start Date: February 2002
Study Completion Date: October 2014
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Nelfinavir (Viracept)

Drug: Nelfinavir
Other Name: Viracept
Active Comparator: Efavirenz (Sustiva)

Drug: Efavirenz

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.



Ages Eligible for Study: 18 Years to 70 Years  
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.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: 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
More Information

More Information

Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00457665   History of Changes  
Other Study ID Numbers: R01-56583  
Study First Received: April 4, 2007  
Last Updated: May 8, 2019  

Keywords provided by University of Texas Southwestern Medical Center:

Treatment Experienced

Additional relevant MeSH terms:
Nelfinavir processed this data on May 24, 2020
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