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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.
First Received: August 25, 2000   Last Updated: August 2, 2007   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00006190
  Purpose

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 Intervention Phase
HIV Infections
Lipodystrophy
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Lamivudine
Drug: Efavirenz
Phase IV

Study Type: Interventional
Study Design: Diagnostic, Double-Blind, Placebo Control
Official Title: The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: November 2000
Estimated Study Completion Date: November 2001
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006190

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9103
Sponsors and 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
  More Information

Publications:
Study ID Numbers: lipod, RO1DK56583-01
Study First Received: August 25, 2000
Last Updated: August 2, 2007
ClinicalTrials.gov Identifier: NCT00006190     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lipodystrophy
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Metabolic Diseases
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on February 08, 2010