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- Title
Abacavir Substitution for Nucleoside Analogs in Patients With HIV Lipoatrophy: A Randomized Trial.
- Authors
Carr, Andrew; Workman, Cassy; Smith, Don E.; Hoy, Jennifer; Hudson, Jeff; Doong, Nicholas; Martin, Allison; Amin, Janaki; Freund, Judith; Law, Matthew; Cooper, David A.
- Abstract
Context: Peripheral lipoatrophy may complicate antiretroviral therapy of human immunodeficiency virus (HIV) infection, often related to duration and type of nucleoside analog therapy, and may have a mitochondrial pathogenesis. No proven therapy exists for lipoatrophy, but abacavir is a nucleoside analog that may be less toxic to mitochondria. Objective: To determine if substitution of stavudine or zidovudine with abacavir improves HIV lipoatrophy without affecting control of HIV replication. Design: Randomized, open-label 24-week study. Setting: Seventeen hospital HIV outpatient clinics and primary care centers in Australia and England, with randomization from June 2000 through January 2001. Participants: A total of 111 adults (109 men) with moderate or severe lipoatrophy who were receiving stavudine (n = 85) or zidovudine (n = 26) and had stable plasma HIV RNA levels below 400 copies/mL and no prior abacavir therapy. Intervention: Patients were randomly assigned to switch from stavudine or zidovudine to abacavir, 300 mg twice per day, while continuing all other antiretroviral therapy (n = 54) or to continue all antiretroviral therapy (n = 57). Main Outcome Measures: The primary end point was limb fat mass, measured by dual-energy x-ray absorptiometry; key secondary end points were plasma HIV RNA levels, adverse events, physician-assessed (via subjective measures) lipodystrophy severity, total and central fat mass, and fasting metabolic (lipid, glycemic, and lactate) levels. Results: There was a significant increase in limb fat in the abacavir group relative to the stavudine/zidovudine group (0.39 vs 0.08 kg; mean difference, 0.31; 95% confidence interval [CI], 0.06-0.57 kg), as well as significant relative increases in subcutaneous thigh (P = .01), arm (P<.001), and abdominal (P = .001) fat areas on computed tomography. Switching had no significant effect on secondary end points, including plasma HIV RNA (for unadjusted comparison between groups at week 24,...
- Subjects
AZIDOTHYMIDINE; MEDICAL care of HIV-positive persons; ADIPOSE tissues; VIRAL replication
- Publication
JAMA: Journal of the American Medical Association, 2002, Vol 288, Issue 2, p207
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.288.2.207