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The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076)

The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076)
The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076)
OBJECTIVE: To describe the effect of zidovudine on human immunodeficiency virus type 1 (HIV-1) and on the course of disease in infants who became infected while they and their mothers received zidovudine preventive therapy or placebo in Pediatric AIDS Clinical Trials Group Protocol 076.

STUDY DESIGN: Observational substudy of a multicenter, randomized, double-blind, placebo-controlled trial.

METHODS: We compared the progression of disease, timing of HIV-1 transmission, and the plasma HIV-1 RNA level in infected infants of mother-infant pairs who were randomly assigned to receive zidovudine (n = 14) or placebo (n = 43). The development of genotypic zidovudine resistance was assessed among infected infants in the zidovudine treatment group.

RESULTS: In this limited study, zidovudine therapy during pregnancy and labor and in the neonatal period for 6 weeks failed to have a major effect on rapid progression of disease, timing of transmission, and viral replication in HIV-infected infants. When the zidovudine treatment regimen failed to prevent maternal-infant transmission of HIV-1, resistance to zidovudine did not develop during study treatment.

CONCLUSIONS: Our study supports the safety of zidovudine use in pregnancy and in the newborn period but demonstrates the continued need for more potent antiretroviral treatment of the infected infant.
0022-3476
717-724
McSherry, G.D.
44452610-8985-4002-9e80-3498d1526fb1
Shapiro, D.E.
8168c292-2521-4137-af97-33e2a92699e8
Coombs, R.W.
58be6864-d0ce-4245-a414-35dcbbbaee37
McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Frenkel, L.M.
69bdea04-0e11-4952-be26-6a90138e11d1
Britto, P.
83d6731e-68c8-4f76-bd1e-2d63a9134d98
Culnane, M.
61c9b4df-4ef2-4867-ae10-3c0329e0bb95
Sperling, R.S.
7174c3cd-1703-4dbb-9e4f-cfd6f9967bd4
McSherry, G.D.
44452610-8985-4002-9e80-3498d1526fb1
Shapiro, D.E.
8168c292-2521-4137-af97-33e2a92699e8
Coombs, R.W.
58be6864-d0ce-4245-a414-35dcbbbaee37
McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Frenkel, L.M.
69bdea04-0e11-4952-be26-6a90138e11d1
Britto, P.
83d6731e-68c8-4f76-bd1e-2d63a9134d98
Culnane, M.
61c9b4df-4ef2-4867-ae10-3c0329e0bb95
Sperling, R.S.
7174c3cd-1703-4dbb-9e4f-cfd6f9967bd4

McSherry, G.D., Shapiro, D.E., Coombs, R.W., McGrath, N., Frenkel, L.M., Britto, P., Culnane, M. and Sperling, R.S. (1999) The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076). Journal of Pediatrics, 134 (6), 717-724. (doi:10.1016/S0022-3476(99)70287-8). (PMID:10356140)

Record type: Article

Abstract

OBJECTIVE: To describe the effect of zidovudine on human immunodeficiency virus type 1 (HIV-1) and on the course of disease in infants who became infected while they and their mothers received zidovudine preventive therapy or placebo in Pediatric AIDS Clinical Trials Group Protocol 076.

STUDY DESIGN: Observational substudy of a multicenter, randomized, double-blind, placebo-controlled trial.

METHODS: We compared the progression of disease, timing of HIV-1 transmission, and the plasma HIV-1 RNA level in infected infants of mother-infant pairs who were randomly assigned to receive zidovudine (n = 14) or placebo (n = 43). The development of genotypic zidovudine resistance was assessed among infected infants in the zidovudine treatment group.

RESULTS: In this limited study, zidovudine therapy during pregnancy and labor and in the neonatal period for 6 weeks failed to have a major effect on rapid progression of disease, timing of transmission, and viral replication in HIV-infected infants. When the zidovudine treatment regimen failed to prevent maternal-infant transmission of HIV-1, resistance to zidovudine did not develop during study treatment.

CONCLUSIONS: Our study supports the safety of zidovudine use in pregnancy and in the newborn period but demonstrates the continued need for more potent antiretroviral treatment of the infected infant.

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e-pub ahead of print date: June 1999
Organisations: Primary Care & Population Sciences, Faculty of Social, Human and Mathematical Sciences

Identifiers

Local EPrints ID: 350541
URI: http://eprints.soton.ac.uk/id/eprint/350541
ISSN: 0022-3476
PURE UUID: 02f482e3-7cf2-4406-b503-23b36ed8cd2f
ORCID for N. McGrath: ORCID iD orcid.org/0000-0002-1039-0159

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Date deposited: 26 Mar 2013 14:04
Last modified: 07 Oct 2020 08:29

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