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

NCT00006190 | Completed Phase 4

• 2 other identifiers: lipod (completed)R01DK056583-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Lipodystrophy

Keywords

Lipoproteins; Insulin resistance; Adipose tissue

Interventions

Nelfinavir mesylate DRUG

Stavudine DRUG

Lamivudine DRUG

Efavirenz DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD4 count \> 200 cells/mm
• HIV RNA (viral load) \<= 100,000 copies/ml
• No previous antiviral therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9103, United States

Location

Related Publications (6)

• Hengel RL, Watts NB, Lennox JL. Benign symmetric lipomatosis associated with protease inhibitors. Lancet. 1997 Nov 29;350(9091):1596. doi: 10.1016/s0140-6736(05)64011-1. No abstract available.

  PMID: 9393341 BACKGROUND

• 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. doi: 10.1097/00002030-199807000-00003.

  PMID: 9619798 BACKGROUND

• Viraben R, Aquilina C. Indinavir-associated lipodystrophy. AIDS. 1998 Apr 16;12(6):F37-9. doi: 10.1097/00002030-199806000-00001.

  PMID: 9583592 BACKGROUND

• Shaw AJ, McLean KA, Evans BA. Disorders of fat distribution in HIV infection. Int J STD AIDS. 1998 Oct;9(10):595-9. doi: 10.1258/0956462981921189.

  PMID: 9819110 BACKGROUND

• 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. doi: 10.1097/00042560-199903010-00003.

  PMID: 10077170 BACKGROUND

• 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. doi: 10.1016/S0140-6736(97)11443-X.

  PMID: 9525364 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Lipodystrophy; Insulin Resistance

Interventions

Nelfinavir; Stavudine; Lamivudine; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine

Study Officials

• Dr. Abhimanyu Garg

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Dr. Dolores Peterson

  University of Texas Southwestern Medical Center

• Dr. Ruth Berggren

  University of Texas Southwestern Medical Center

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 25, 2000
• First Posted: August 28, 2000
• Study Start: November 1, 2000
• Study Completion: November 1, 2001
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

US (1)