A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
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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 4 |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients |
Eligibility| 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| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-9103 | |
| 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:
| 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):
|
Lipoproteins Insulin resistance Adipose tissue |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders |
Metabolic Diseases Stavudine Lamivudine Efavirenz Nelfinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013