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

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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.
    


Study Phase

Phase 4

Study Type

Interventional




Condition

HIV Infections

Intervention

Nelfinavir mesylate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


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

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Dr. Abhimanyu Garg, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006190

Organization ID

lipod (completed)

Secondary IDs

R01DK056583-01


Study Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Study Sponsor

Dr. Abhimanyu Garg, Principal Investigator, UT Southwestern Medical Center


Verification Date

March 2010