A Study to Determine How and Why HIV-Infected Subjects on Anti-Viral Treatment Develop Lipodystrophy
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Lipodystrophy
Intervention: Nelfinavir mesylate (Drug); Stavudine (Drug); Lamivudine (Drug); Efavirenz (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s):
Dr. Abhimanyu Garg, Principal Investigator, Affiliation: UT Southwestern Medical Center
Dr. Dolores Peterson, Affiliation: UT Southwestern Medical Center
Dr. Ruth Berggren, Affiliation: UT Southwestern Medical Center
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.
Clinical Details
Official title:
The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients
Study design: Interventional, Diagnostic, Double-Blind, Placebo Control
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
UT Southwestern Medical Center, Dallas, Texas 75390-9103, United States
Additional Information
Related publications: Hengel RL, Watts NB, Lennox JL. Benign symmetric lipomatosis associated with protease inhibitors. Lancet. 1997 Nov 29;350(9091):1596. No abstract available. Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8. Viraben R, Aquilina C. Indinavir-associated lipodystrophy. AIDS. 1998 Apr 16;12(6):F37-9. Shaw AJ, McLean KA, Evans BA. Disorders of fat distribution in HIV infection. Int J STD AIDS. 1998 Oct;9(10):595-9. Kotler DP, Rosenbaum K, Wang J, Pierson RN. Studies of body composition and fat distribution in HIV-infected and control subjects. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Mar 1;20(3):228-37. Lo JC, Mulligan K, Tai VW, Algren H, Schambelan M. "Buffalo hump" in men with HIV-1 infection. Lancet. 1998 Mar 21;351(9106):867-70.
Starting date:
November 2000
Ending date: November 2001
Last updated: June 23, 2005
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