TY - JOUR
T1 - A randomized study of combined zidovudine-lamivudine versus didanosine monotherapy in children with-symptomatic therapy-naive hiv-1 infection
AU - McKinney, Jr
AU - Johnson, G. M.
AU - Stanley, K.
AU - Yong, F. H.
AU - Keller, A.
AU - O'Donnell, K. J.
AU - Brouwers, P.
AU - Mitchell, W. G.
AU - Yogev, R.
AU - Wara, D. W.
AU - Wiznia, A.
AU - Mofenson, L.
AU - McNamara, J.
AU - Spector, S. A.
AU - Wells, B.
AU - Hodge, J.
AU - Landay, A. L.
AU - Trevithick, D.
AU - Fowler, M. G.
AU - Martinez, A.
AU - Martin-Carpenter, J. L.
AU - Scott, J.
AU - Connaugton, E.
AU - Rutkiewicz, V.
AU - Stokes, B.
AU - Stocker, V.
PY - 1998
Y1 - 1998
N2 - Objective: The Pediatric AIDS Clinical Trials Group (PACTG) Protocol 300 assessed the clinical efficacy and safety of combination zidovudine/lamivudine (ZDV/3TC) compared with either didanosine (ddI) alone or combination ZDV/ddI. Study design: Children with symptomatic human immunodeficiency virus (HIV) infection, 6 weeks through 15 years of age, were stratified according to age and randomly assigned to receive ddI, ZDV/3TC, or ZDV/ddI. The primary endpoint was time to first progression of HIV disease or death. Enrollment in the ZDV/ddI arm stopped after 11 months on the basis of results of PACTG Protocol 162, but blinded follow-up continued. Results: For the 471 children who could be evaluated, the median age was 2.7 years, median CD4 cell count was 699 cells/mm3, and median log10 HIV RNA was 5.1/mL. Median follow-up was 9.4 months. Patients receiving ZDV/3TC had a lower risk of HIV disease progression or death than those receiving ddI alone (15 vs 38 failures, P = .0006) and a lower risk of death (3 vs 15 deaths, P = .0039). Weight and height growth rates, CD4+ cell counts, and RNA concentrations showed results favoring ZDV/3TC. For patients concurrently randomized to all 3 treatment arms, both ZDV/3TC and ZDV/ddI recipients had lower risk of HIV disease progression than those who received ddI alone (P = .0026 and P = .0045). Conclusions: Combination therapy with either ZDV/3TC or ZDV/ddI was superior, as determined by clinical and laboratory measures, to monotherapy with ddI.
AB - Objective: The Pediatric AIDS Clinical Trials Group (PACTG) Protocol 300 assessed the clinical efficacy and safety of combination zidovudine/lamivudine (ZDV/3TC) compared with either didanosine (ddI) alone or combination ZDV/ddI. Study design: Children with symptomatic human immunodeficiency virus (HIV) infection, 6 weeks through 15 years of age, were stratified according to age and randomly assigned to receive ddI, ZDV/3TC, or ZDV/ddI. The primary endpoint was time to first progression of HIV disease or death. Enrollment in the ZDV/ddI arm stopped after 11 months on the basis of results of PACTG Protocol 162, but blinded follow-up continued. Results: For the 471 children who could be evaluated, the median age was 2.7 years, median CD4 cell count was 699 cells/mm3, and median log10 HIV RNA was 5.1/mL. Median follow-up was 9.4 months. Patients receiving ZDV/3TC had a lower risk of HIV disease progression or death than those receiving ddI alone (15 vs 38 failures, P = .0006) and a lower risk of death (3 vs 15 deaths, P = .0039). Weight and height growth rates, CD4+ cell counts, and RNA concentrations showed results favoring ZDV/3TC. For patients concurrently randomized to all 3 treatment arms, both ZDV/3TC and ZDV/ddI recipients had lower risk of HIV disease progression than those who received ddI alone (P = .0026 and P = .0045). Conclusions: Combination therapy with either ZDV/3TC or ZDV/ddI was superior, as determined by clinical and laboratory measures, to monotherapy with ddI.
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U2 - 10.1016/S0022-3476(98)70057-5
DO - 10.1016/S0022-3476(98)70057-5
M3 - Article
C2 - 9787687
AN - SCOPUS:0031694944
SN - 0022-3476
VL - 133
SP - 500
EP - 508
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 4
ER -