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A Study to Determine How and Why HIV-Infected Subjects on Anti-Viral Treatment Develop Lipodystrophy

This study has been completed.
Study NCT00006190.   Last updated on August 2, 2007.   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Descriptive Information Fields
Brief Title  A Study to Determine How and Why HIV-Infected Subjects on Anti-Viral Treatment Develop Lipodystrophy
Official Title  The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients
Brief Summary

HIV infection is a major global health problem. Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. However, such therapy has been associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body shape changes; typically thinning and loss of fat from the arms, legs and face, with increased fat appearing in the abdomen and neck. There are also metabolic changes which occur, and subjects can develop increased triglycerides, increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance. This study will take HIV positive subjects who have not yet started antiviral medications (treatment naive)and randomly assign them to one of two treatment arms. These treatment arms will be: Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs. Understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Diagnostic, Double-Blind, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Lipodystrophy
Intervention  Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Lamivudine
Drug: Efavirenz
MEDLINE PMIDs 9393341,   9619798,   9583592,   9819110,   10077170,   9525364
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  November 2000
Completion Date November 2001
Eligibility Criteria 

Inclusion Criteria:

  • CD4 count > 200 cells/mm
  • HIV RNA (viral load) <= 100,000 copies/ml
  • No previous antiviral therapy

Exclusion Criteria:

  • AIDS or opportunistic infections
  • Active intravenous drug users
  • Use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, oxandrolone, megace, dehydroepiandrosterone.
  • Subjects with diabetes mellitus
  • Subjects who consume > 2 alcoholic drinks per day
  • Pregnant women, premenopausal women unless adequate birth control is in use.
  • Acute or chronic liver diseases, liver enzymes elevations > 2.5 times the upper limit of normal.
  • Anemia, an Hct < 35% for men, or < 32% for women.
  • Abnormal thyroid function tests.
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00006190
Organization ID lipod
Secondary IDs †† RO1DK56583-01
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ††
Investigators 
Principal Investigator:     Dr. Abhimanyu Garg     UT Southwestern Medical Center    
Investigator:     Dr. Dolores Peterson     UT Southwestern Medical Center    
Investigator:     Dr. Ruth Berggren     UT Southwestern Medical Center    
Information Provided By National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date July 2003
First Received Date  August 25, 2000
Last Updated Date August 2, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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