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

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ClinicalTrials.gov Identifier: NCT00006190
Recruitment Status : Completed
First Posted : August 28, 2000
Last Update Posted : March 2, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Lipodystrophy Drug: Nelfinavir mesylate Drug: Stavudine Drug: Lamivudine Drug: Efavirenz Phase 4

Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Diagnostic
Official Title: The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients
Study Start Date : November 2000
Estimated Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00006190

United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9103
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Dr. Abhimanyu Garg UT Southwestern Medical Center
OverallOfficial: Dr. Dolores Peterson UT Southwestern Medical Center
OverallOfficial: Dr. Ruth Berggren UT Southwestern Medical Center

ClinicalTrials.gov Identifier: NCT00006190     History of Changes
Other Study ID Numbers: lipod (completed)
R01DK056583-01 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2000    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Insulin resistance
Adipose tissue

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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers