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

This study has been completed.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
First received: August 25, 2000
Last updated: March 1, 2010
Last verified: March 2010
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
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Lamivudine
Drug: Efavirenz
Phase 4

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Diagnostic
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

ClinicalTrials.gov Identifier: NCT00006190     History of Changes
Other Study ID Numbers: lipod (completed)  RO1DK56583-01 
Study First Received: August 25, 2000
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases
Skin Diseases, Metabolic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016