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Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128)

Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128)
Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128)
The current dosage of zidovudine for children is 180 mg/m2 every 6 h. To investigate whether a lower dosage was equally effective, human immunodeficiency virus (HIV)-infected children (3 months to 12 years) with mild to moderate symptoms were randomly assigned to receive either high-dose (180 mg/m2/dose) or low-dose (90 mg/m2/dose) zidovudine (double-blind). Treatments were compared with respect to neuropsychologic function, survival, clinical and laboratory evidence of disease progression, and safety and tolerance. Four hundred twenty-six HIV-infected children were enrolled; median time for receipt of study drug was 35 months. Zidovudine in either dose was well tolerated, with no difference in efficacy or tolerance by treatment group using any clinical or laboratory parameter. In children with mild to moderate disease, a reduction of zidovudine to 90 mg/m2/dose will result in substantial cost savings and should be the recommended dose.
0022-1899
1097-1106
Brady, M.
be3ca442-d653-4384-b408-09fd2be2b7f9
McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Brouwers, P.
3c605044-15c1-43fa-abc8-f61620a2cd2c
Gelber, R.
544720ad-fa9c-4813-bca2-b25340a62727
Fowler, R.
233a405e-e272-4c48-8c76-29f939d0533f
Weintrub, P.
d36c4d21-0e06-4594-90fe-43f2a11ba6cd
the Pediatric AIDS Clinical Trials Group, None
6f7d55a0-e88b-4399-befb-161199bf8180
Brady, M.
be3ca442-d653-4384-b408-09fd2be2b7f9
McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Brouwers, P.
3c605044-15c1-43fa-abc8-f61620a2cd2c
Gelber, R.
544720ad-fa9c-4813-bca2-b25340a62727
Fowler, R.
233a405e-e272-4c48-8c76-29f939d0533f
Weintrub, P.
d36c4d21-0e06-4594-90fe-43f2a11ba6cd
the Pediatric AIDS Clinical Trials Group, None
6f7d55a0-e88b-4399-befb-161199bf8180

Brady, M., McGrath, N., Brouwers, P., Gelber, R., Fowler, R., Weintrub, P. and the Pediatric AIDS Clinical Trials Group, None (1996) Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128). The Journal of Infectious Diseases, 173 (5), 1097-1106. (doi:10.1093/infdis/173.5.1097). (PMID:8627060)

Record type: Article

Abstract

The current dosage of zidovudine for children is 180 mg/m2 every 6 h. To investigate whether a lower dosage was equally effective, human immunodeficiency virus (HIV)-infected children (3 months to 12 years) with mild to moderate symptoms were randomly assigned to receive either high-dose (180 mg/m2/dose) or low-dose (90 mg/m2/dose) zidovudine (double-blind). Treatments were compared with respect to neuropsychologic function, survival, clinical and laboratory evidence of disease progression, and safety and tolerance. Four hundred twenty-six HIV-infected children were enrolled; median time for receipt of study drug was 35 months. Zidovudine in either dose was well tolerated, with no difference in efficacy or tolerance by treatment group using any clinical or laboratory parameter. In children with mild to moderate disease, a reduction of zidovudine to 90 mg/m2/dose will result in substantial cost savings and should be the recommended dose.

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Published date: May 1996
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 350551
URI: https://eprints.soton.ac.uk/id/eprint/350551
ISSN: 0022-1899
PURE UUID: 330b3f0b-189d-4197-b825-cd8d91bb64f7
ORCID for N. McGrath: ORCID iD orcid.org/0000-0002-1039-0159

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Date deposited: 26 Mar 2013 14:52
Last modified: 08 Oct 2019 00:36

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