Journal article
Combination nucleoside analog reverse transcriptase inhibitor(s) plus nevirapine, nelfinavir, or ritonavir in stable antiretroviral therapy-experienced HIV-infected children : Week 24 results of a randomized controlled trial-PACTG 377
AIDS research and human retroviruses, Vol.16(12), pp.1113-1121
2000
DOI: 10.1089/088922200414956
PMID: 10954886
Abstract
One hundred eighty-one antiretroviral-experienced, protease inhibitor-naive, clinically stable HIV-infected children between 4 months and 17 years of age were randomly assigned to receive one of four combination regimens to evaluate the change in plasma HIV RNA, safety, and tolerance when changing antiretroviral therapy to a protease inhibitor-containing combination regimen. All four regimens contained stavudine; in addition children received nevirapine plus ritonavir, lamivudine plus nelfinavir, nevirapine plus nelfinavir, or lamivudine plus nevirapine plus nelfinavir. Twelve additional children chose to receive stavudine plus lamivudine plus nelfinavir, with nelfinavir given bid, rather than tid as for the main regimens. Overall, 51% (89/176; 95% CI 43-58%) of the children on the randomized portion of the study had an HIV RNA response (≤400 copies/ml) on at least two of the three HIV RNA determinations taken at Weeks 8, 12, and 16. At Week 24 the proportion of children with an HIV RNA response still on initial therapy was 47% (83/176; 95% CI 40-55%) and ranged from 41 to 61% for the four randomized treatment arms. Rash was frequently seen (27%) on the treatment arms containing nevirapine. At Week 24 64% (7/11, 95% CI 31-89%) of the children on the bid nelfinavir combination regimen were still on initial therapy with an HIV RNA response as compared with 46% (23/50; 95% CI 32-61%) on the corresponding tid nelfinavir combination regimen. A change in antiretroviral therapy to a protease inhibitor-containing regimen was associated with a virological response rate of approximately 50% for this patient population.
Details
- Title: Subtitle
- Combination nucleoside analog reverse transcriptase inhibitor(s) plus nevirapine, nelfinavir, or ritonavir in stable antiretroviral therapy-experienced HIV-infected children : Week 24 results of a randomized controlled trial-PACTG 377
- Creators
- Andrew Wiznia - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesKenneth Stanley - Harvard School of Public Health, Boston, Massachusetts 02115, United StatesPaul Krogstad - University of California, Los Angeles School of Medicine, Los Angeles, California 90095, United StatesGeorge Johnson - Medical University of South Carolina, Charleston, South Carolina 29425, United StatesSophia Lee - Harvard School of Public Health, Boston, Massachusetts 02115, United StatesJames McNamara - National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892, United StatesJohn Moye - National Institute of Child Health and Human Development, NIH, Bethesda Maryland 20892, United StatesJ Brooks Jackson - Johns Hopkins University, Baltimore, Maryland 21287, United StatesHermann Mendez - Children's Medical Center of Brooklyn, Brooklyn, New York 11203, United StatesRosaura Aguayo - Ramon Ruiz Aranu University Hospital, Bayamon, Puerto Rico 00956, Puerto RicoArry Dieudonne - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesAndrea Kovacs - University of Southern CaliforniaM BAMJI - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesE ABRAMS - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesS RANA - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesJ SEVER - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United StatesSharon Nachman - Pediatric HIV Services, Jacobi Medical Center, Bronx, New York 10461, United States
- Resource Type
- Journal article
- Publication Details
- AIDS research and human retroviruses, Vol.16(12), pp.1113-1121
- Publisher
- Liebert; Larchmont, NY
- DOI
- 10.1089/088922200414956
- PMID
- 10954886
- ISSN
- 0889-2229
- eISSN
- 1931-8405
- Language
- English
- Date published
- 2000
- Academic Unit
- Pathology; VPMA - Administration; Internal Medicine
- Record Identifier
- 9984047754002771
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