Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children

Janet A. Englund, Carol J. Baker, Claire Raskino, Ross E. Mckinney, Barbara Petrie, Mary Glenn Fowler, Deborah Pearson, Anne Gershon, George D. Mcsherry, Elaine J. Abrams, Jenny Schliozberg, John L. Sullivan, Rachel Behrman, James C. Connor, Seth Hetherington, Marta H. Lifschitz, Colin McLaren, Herman Mendez, Karen Millison, Jack MoyeMolly Nozyce, Karen O'Donnell, Lynette Purdue, David Schoenfeld, Gwendolyn B Scott, Stephen A. Spector, Diane W. Wara

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Abstract

Background: Zidovudine has been the drug of choice for the initial treatment of symptomatic children infected with the human immunodeficiency virus (HIV). This trial was designed to assess the efficacy and safety of treatment with zidovudine alone as compared with either didanosine alone or combination therapy with zidovudine plus didanosine. Methods: In this multicenter, double-blind study, symptomatic HIV-infected children 3 months through 18 years of age were stratified according to age (<30 months or ≤30 months) and randomly assigned to receive zidovudine, didanosine, or zidovudine plus didanosine. The primary end point was length of time to death or to progression of HIV disease. Results: Of the 831 children who could be evaluated, 92 percent had never received antiretroviral therapy and 90 percent had acquired HIV perinatally. An interim analysis (median follow-up, 23 months) showed a significantly higher risk of HIV-disease progression or death in patients receiving zidovudine alone than in those receiving combination therapy (relative risk, 0.61; 95 percent confidence interval, 0.42 to 0.88; P=0.007). The study arm with zidovudine alone was stopped and unblinded; the other two treatment arms were continued. At the end of the study, didanosine alone had an efficacy similar to that of zidovudine plus didanosine (median follow-up, 32 months) (relative risk of disease progression or death, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.91). A significantly lower risk of anemia or neutropenia was seen in patients receiving didanosine alone (P=0.036). Conclusions: In symptomatic HIV-infected children, treatment with either didanosine alone or zidovudine plus didanosine was more effective than treatment with zidovudine alone. The efficacy of didanosine alone was similar to that of the combination therapy and was associated with less hematologic toxicity.

Original languageEnglish
Pages (from-to)1704-1712
Number of pages9
JournalNew England Journal of Medicine
Volume336
Issue number24
DOIs
StatePublished - Jun 26 1997

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Didanosine
Zidovudine
HIV
Therapeutics
Virus Diseases
Disease Progression
Confidence Intervals
Neutropenia
Double-Blind Method
Anemia

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Englund, J. A., Baker, C. J., Raskino, C., Mckinney, R. E., Petrie, B., Fowler, M. G., ... Wara, D. W. (1997). Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. New England Journal of Medicine, 336(24), 1704-1712. https://doi.org/10.1056/NEJM199706123362403

Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. / Englund, Janet A.; Baker, Carol J.; Raskino, Claire; Mckinney, Ross E.; Petrie, Barbara; Fowler, Mary Glenn; Pearson, Deborah; Gershon, Anne; Mcsherry, George D.; Abrams, Elaine J.; Schliozberg, Jenny; Sullivan, John L.; Behrman, Rachel; Connor, James C.; Hetherington, Seth; Lifschitz, Marta H.; McLaren, Colin; Mendez, Herman; Millison, Karen; Moye, Jack; Nozyce, Molly; O'Donnell, Karen; Purdue, Lynette; Schoenfeld, David; Scott, Gwendolyn B; Spector, Stephen A.; Wara, Diane W.

In: New England Journal of Medicine, Vol. 336, No. 24, 26.06.1997, p. 1704-1712.

Research output: Contribution to journalArticle

Englund, JA, Baker, CJ, Raskino, C, Mckinney, RE, Petrie, B, Fowler, MG, Pearson, D, Gershon, A, Mcsherry, GD, Abrams, EJ, Schliozberg, J, Sullivan, JL, Behrman, R, Connor, JC, Hetherington, S, Lifschitz, MH, McLaren, C, Mendez, H, Millison, K, Moye, J, Nozyce, M, O'Donnell, K, Purdue, L, Schoenfeld, D, Scott, GB, Spector, SA & Wara, DW 1997, 'Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children', New England Journal of Medicine, vol. 336, no. 24, pp. 1704-1712. https://doi.org/10.1056/NEJM199706123362403
Englund, Janet A. ; Baker, Carol J. ; Raskino, Claire ; Mckinney, Ross E. ; Petrie, Barbara ; Fowler, Mary Glenn ; Pearson, Deborah ; Gershon, Anne ; Mcsherry, George D. ; Abrams, Elaine J. ; Schliozberg, Jenny ; Sullivan, John L. ; Behrman, Rachel ; Connor, James C. ; Hetherington, Seth ; Lifschitz, Marta H. ; McLaren, Colin ; Mendez, Herman ; Millison, Karen ; Moye, Jack ; Nozyce, Molly ; O'Donnell, Karen ; Purdue, Lynette ; Schoenfeld, David ; Scott, Gwendolyn B ; Spector, Stephen A. ; Wara, Diane W. / Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. In: New England Journal of Medicine. 1997 ; Vol. 336, No. 24. pp. 1704-1712.
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abstract = "Background: Zidovudine has been the drug of choice for the initial treatment of symptomatic children infected with the human immunodeficiency virus (HIV). This trial was designed to assess the efficacy and safety of treatment with zidovudine alone as compared with either didanosine alone or combination therapy with zidovudine plus didanosine. Methods: In this multicenter, double-blind study, symptomatic HIV-infected children 3 months through 18 years of age were stratified according to age (<30 months or ≤30 months) and randomly assigned to receive zidovudine, didanosine, or zidovudine plus didanosine. The primary end point was length of time to death or to progression of HIV disease. Results: Of the 831 children who could be evaluated, 92 percent had never received antiretroviral therapy and 90 percent had acquired HIV perinatally. An interim analysis (median follow-up, 23 months) showed a significantly higher risk of HIV-disease progression or death in patients receiving zidovudine alone than in those receiving combination therapy (relative risk, 0.61; 95 percent confidence interval, 0.42 to 0.88; P=0.007). The study arm with zidovudine alone was stopped and unblinded; the other two treatment arms were continued. At the end of the study, didanosine alone had an efficacy similar to that of zidovudine plus didanosine (median follow-up, 32 months) (relative risk of disease progression or death, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.91). A significantly lower risk of anemia or neutropenia was seen in patients receiving didanosine alone (P=0.036). Conclusions: In symptomatic HIV-infected children, treatment with either didanosine alone or zidovudine plus didanosine was more effective than treatment with zidovudine alone. The efficacy of didanosine alone was similar to that of the combination therapy and was associated with less hematologic toxicity.",
author = "Englund, {Janet A.} and Baker, {Carol J.} and Claire Raskino and Mckinney, {Ross E.} and Barbara Petrie and Fowler, {Mary Glenn} and Deborah Pearson and Anne Gershon and Mcsherry, {George D.} and Abrams, {Elaine J.} and Jenny Schliozberg and Sullivan, {John L.} and Rachel Behrman and Connor, {James C.} and Seth Hetherington and Lifschitz, {Marta H.} and Colin McLaren and Herman Mendez and Karen Millison and Jack Moye and Molly Nozyce and Karen O'Donnell and Lynette Purdue and David Schoenfeld and Scott, {Gwendolyn B} and Spector, {Stephen A.} and Wara, {Diane W.}",
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T1 - Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children

AU - Englund, Janet A.

AU - Baker, Carol J.

AU - Raskino, Claire

AU - Mckinney, Ross E.

AU - Petrie, Barbara

AU - Fowler, Mary Glenn

AU - Pearson, Deborah

AU - Gershon, Anne

AU - Mcsherry, George D.

AU - Abrams, Elaine J.

AU - Schliozberg, Jenny

AU - Sullivan, John L.

AU - Behrman, Rachel

AU - Connor, James C.

AU - Hetherington, Seth

AU - Lifschitz, Marta H.

AU - McLaren, Colin

AU - Mendez, Herman

AU - Millison, Karen

AU - Moye, Jack

AU - Nozyce, Molly

AU - O'Donnell, Karen

AU - Purdue, Lynette

AU - Schoenfeld, David

AU - Scott, Gwendolyn B

AU - Spector, Stephen A.

AU - Wara, Diane W.

PY - 1997/6/26

Y1 - 1997/6/26

N2 - Background: Zidovudine has been the drug of choice for the initial treatment of symptomatic children infected with the human immunodeficiency virus (HIV). This trial was designed to assess the efficacy and safety of treatment with zidovudine alone as compared with either didanosine alone or combination therapy with zidovudine plus didanosine. Methods: In this multicenter, double-blind study, symptomatic HIV-infected children 3 months through 18 years of age were stratified according to age (<30 months or ≤30 months) and randomly assigned to receive zidovudine, didanosine, or zidovudine plus didanosine. The primary end point was length of time to death or to progression of HIV disease. Results: Of the 831 children who could be evaluated, 92 percent had never received antiretroviral therapy and 90 percent had acquired HIV perinatally. An interim analysis (median follow-up, 23 months) showed a significantly higher risk of HIV-disease progression or death in patients receiving zidovudine alone than in those receiving combination therapy (relative risk, 0.61; 95 percent confidence interval, 0.42 to 0.88; P=0.007). The study arm with zidovudine alone was stopped and unblinded; the other two treatment arms were continued. At the end of the study, didanosine alone had an efficacy similar to that of zidovudine plus didanosine (median follow-up, 32 months) (relative risk of disease progression or death, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.91). A significantly lower risk of anemia or neutropenia was seen in patients receiving didanosine alone (P=0.036). Conclusions: In symptomatic HIV-infected children, treatment with either didanosine alone or zidovudine plus didanosine was more effective than treatment with zidovudine alone. The efficacy of didanosine alone was similar to that of the combination therapy and was associated with less hematologic toxicity.

AB - Background: Zidovudine has been the drug of choice for the initial treatment of symptomatic children infected with the human immunodeficiency virus (HIV). This trial was designed to assess the efficacy and safety of treatment with zidovudine alone as compared with either didanosine alone or combination therapy with zidovudine plus didanosine. Methods: In this multicenter, double-blind study, symptomatic HIV-infected children 3 months through 18 years of age were stratified according to age (<30 months or ≤30 months) and randomly assigned to receive zidovudine, didanosine, or zidovudine plus didanosine. The primary end point was length of time to death or to progression of HIV disease. Results: Of the 831 children who could be evaluated, 92 percent had never received antiretroviral therapy and 90 percent had acquired HIV perinatally. An interim analysis (median follow-up, 23 months) showed a significantly higher risk of HIV-disease progression or death in patients receiving zidovudine alone than in those receiving combination therapy (relative risk, 0.61; 95 percent confidence interval, 0.42 to 0.88; P=0.007). The study arm with zidovudine alone was stopped and unblinded; the other two treatment arms were continued. At the end of the study, didanosine alone had an efficacy similar to that of zidovudine plus didanosine (median follow-up, 32 months) (relative risk of disease progression or death, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.91). A significantly lower risk of anemia or neutropenia was seen in patients receiving didanosine alone (P=0.036). Conclusions: In symptomatic HIV-infected children, treatment with either didanosine alone or zidovudine plus didanosine was more effective than treatment with zidovudine alone. The efficacy of didanosine alone was similar to that of the combination therapy and was associated with less hematologic toxicity.

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