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15 January 2004

Volume 38, Number 2
Clinical Infectious Diseases 2004;38:263–270
© 2004 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2004/3802-0012$15.00
DOI: 10.1086/380790
HIV/AIDS MAJOR ARTICLE

Improvement in Lipoatrophy Associated with Highly Active Antiretroviral Therapy in Human Immunodeficiency Virus–Infected Patients Switched from Stavudine to Abacavir or Zidovudine: The Results of the TARHEEL Study

Grace A. McComsey,1

Douglas J. Ward,2

Siegrid M. Hessenthaler,3

Michael G. Sension,4

Peter Shalit,5

J. Tyler Lonergan,6

Robin L. Fisher,3

Vanessa C. Williams,3 and

Jaime E. Hernandez,3 for

the Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL; ESS40010) Study Team

1Case Western Reserve, Cleveland, Ohio; 2Dupont Circle Physicians Group, Washington, DC; 3GlaxoSmithKline, Research Triangle Park, North Carolina; 4North Broward Hospital District, Ft. Lauderdale, Florida; 5Swedish Medical Center, Seattle, Washington; and 6University of California at San Diego Antiviral Research Center, San Diego, California

Stavudine use is a contributing factor for lipoatrophy, whereas use of abacavir or zidovudine is less likely to cause this complication. The TARHEEL study was a 48-week, open-label study that assessed changes in lipoatrophy after abacavir (86 patients [73%]) or zidovudine (32 patients [27%]), 300 mg twice daily, was substituted for stavudine for 118 human immunodeficiency virus (HIV)–infected patients (HIV type 1 RNA level, <400 copies/mL) with virological suppression who had developed lipoatrophy after 6 months of stavudine-based treatment. At week 48, full-body dual-energy x-ray absorptiometry demonstrated a median increase in arm fat of 35%, leg fat of 12%, and trunk fat of 18%, compared with the baseline level. These improvements coincided with fat gain in lipoatrophic areas that was documented by computerized tomography. Results of a “body image” questionnaire showed that a substantial percentage of patients reported some or a lot of fat gain in the arms (22%), legs (18%), buttocks (19%), and face (27%). HIV suppression was maintained over the study period. In conclusion, replacing stavudine with abacavir or zidovudine resulted in improvement in stavudine-induced lipoatrophy.

Received 2 April 2003; accepted 5 September 2003; electronically published 18 December 2003.

Reprints or correspondence: Dr. Grace A. McComsey, Dept. of Pediatrics, Div. of Infectious Diseases, Rainbow Babies and Children Hospital, 11100 Euclid Ave., Cleveland, OH 44106 ().

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  • Presented in part: 3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, Athens, Greece, 23–26 October 2001 [poster 92]; 9th Conference on Retroviruses and Opportunistic Infections, Seattle, Washington, 24–28 February 2002 [poster 701T]; 4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, San Diego, California, 22–25 September 2002; and 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, California, 27–30 September 2002 [posters H-1929 and H-1930 and oral presentation 21].

    Financial support: GlaxoSmithKline.

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