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In Pediatric AIDS Clinical Trials Group 377, antiretroviral therapy–experienced children were randomized to 4 treatment arms that included different combinations of stavudine, lamivudine (3TC), nevirapine (Nvp), nelfinavir (Nfv), and ritonavir (Rtv). Previous treatment with zidovudine (Zdv), didanosine (ddI), or zalcitabine (ddC) was acceptable. Drug resistance (R) mutations were assessed before study treatment (baseline) and at virologic failure. ZdvR, ddIR, and ddCR mutations were detected frequently at baseline but were not associated with virologic failure. Children with drug resistance mutations at baseline had greater reductions in virus load over time than did children who did not. NvpR and 3TCR mutations were detected frequently at virologic failure, and NvpR mutations were more common among children receiving 3-drug versus 4-drug Nvp-containing regimens. Children who were maintained on their study regimen after virologic failure accumulated additional NvpR and 3TCR mutations plus RtvR and NfvR mutations. However, RtvR and NfvR mutations were detected at unexpectedly low rates.


Article written by researchers from the Department of Pathology, Johns Hopkins Medical Institutions;Department of Pediatrics, University of California, Los Angeles School of Medicine;Statistical Data Analysis Center, Harvard School of Public Health;Department of Pediatrics, Jacobi Medical Center, Albert Einstein College of Medicine;Department of Pediatrics, State University of New York, Stony Brook;Department of Pediatrics, Medical University of South Carolina;and Department of Pediatrics, University of Medicine and Dentistry of New Jersey. Published in The Journal of Infectious Diseases, June 15, 2001, volume 183, pages 1732-1738. Includes abstract, references, and tables.