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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006190
First received: August 25, 2000
Last updated: March 1, 2010
Last verified: March 2010

August 25, 2000
March 1, 2010
November 2000
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Complete list of historical versions of study NCT00006190 on ClinicalTrials.gov Archive Site
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A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients

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.

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Interventional
Phase 4
Masking: Double-Blind
Primary Purpose: Diagnostic
  • HIV Infections
  • Lipodystrophy
  • Drug: Nelfinavir mesylate
  • Drug: Stavudine
  • Drug: Lamivudine
  • Drug: Efavirenz
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2001
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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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006190
lipod (completed), RO1DK56583-01
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

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