A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators

Show simplified metadata
dc.contributor.authorLallemant, Marc
dc.contributor.authorJourdain, Gonzague
dc.contributor.authorLe Coeur, Sophie
dc.contributor.authorKim, Soyeon
dc.contributor.authorKoetsawang, Suporn
dc.contributor.authorComeau, Anne Marie
dc.contributor.authorPhoolcharoen, Wiput
dc.contributor.authorEssex, Max
dc.contributor.authorMcIntosh, Kenneth
dc.contributor.authorVithayasai, Vicharn
dc.contributor.departmentNew England Newborn Screening Program
dc.contributor.departmentDepartment of Pediatrics
dc.date2022-08-11T08:10:10.000
dc.date.accessioned2022-08-23T16:58:00Z
dc.date.available2022-08-23T16:58:00Z
dc.date.issued2000-10-05
dc.date.submitted2012-04-09
dc.description.abstractBACKGROUND: The optimal duration of zidovudine administration to prevent perinatal transmission of human immunodeficiency virus type 1 (HIV-1) should be determined to facilitate its use in areas where resources are limited. METHODS: We conducted a randomized, double-blind equivalence trial of zidovudine starting in the mother at 28 weeks' gestation, with 6 weeks of treatment in the infant (the long-long regimen), which is similar to protocol 076; zidovudine starting at 35 weeks' gestation, with 3 days of treatment in the infant (the short-short regimen); a long-short regimen; and a short-long regimen. The mothers received zidovudine orally during labor. The infants were fed formula and were tested for HIV DNA at 1, 45, 120, and 180 days. After the first interim analysis, the short-short regimen was stopped. RESULTS: A total of 1437 women were enrolled. At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long-long regimen and 10.5 percent for the short-short regimen (P=0.004). For the entire study period, the transmission rates were 6.5 percent (95 percent confidence interval, 4.1 to 8.9 percent) for the long-long regimen, 4.7 percent (95 percent confidence interval, 2.4 to 7.0 percent) for the long-short regimen, and 8.6 percent (95 percent confidence interval, 5.6 to 11.6 percent) for the short-long regimen. The rate of in utero transmission was significantly higher with the two regimens with shorter maternal treatment (5.1 percent) than with the two with longer maternal treatment (1.6 percent). CONCLUSIONS: The short-short zidovudine regimen is inferior to the long-long regimen and leads to a higher rate of perinatal HIV transmission. The long-short, short-long, and long-long regimens had equivalent efficacy. However, the higher rate of in utero transmission with the short-long regimen suggests that longer treatment of the infant cannot substitute for longer treatment of the mother.
dc.identifier.citationN Engl J Med. 2000 Oct 5;343(14):982-91. <a href="http://dx.doi.org/10.1056/NEJM200010053431401">Link to article on publisher's site</a>
dc.identifier.contextkey2742421
dc.identifier.doi10.1056/NEJM200010053431401
dc.identifier.issn0028-4793 (Linking)
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/peds_genetics/2
dc.identifier.pmid11018164
dc.identifier.submissionpathpeds_genetics/2
dc.identifier.urihttps://hdl.handle.net/20.500.14038/43274
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=11018164&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1056/NEJM200010053431401
dc.rightsCopyright © 2000 Massachusetts Medical Society. PDF posted as allowed by the publisher’s Author Permissions policy at https://www.nejm.org/author-center/permissions.
dc.source.issue14
dc.source.journaltitleThe New England journal of medicine
dc.source.pages982-91
dc.source.volume343
dc.subjectAdult
dc.subjectAnti-HIV Agents
dc.subjectDouble-Blind Method
dc.subjectDrug Administration Schedule
dc.subjectFemale
dc.subjectHIV Infections
dc.subjectHumans
dc.subjectInfant
dc.subjectInfant, Newborn
dc.subjectInfectious Disease Transmission, Vertical
dc.subjectLabor, Obstetric
dc.subjectMale
dc.subjectPregnancy
dc.subjectPregnancy Complications, Infectious
dc.subjectPregnancy Outcome
dc.subjectThailand
dc.subjectZidovudine
dc.subjectGenetics and Genomics
dc.subjectMedical Genetics
dc.subjectPediatrics
dc.titleA trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators
dc.typeJournal Article
dspace.entity.typePublication
html.description.abstract<p>BACKGROUND: The optimal duration of zidovudine administration to prevent perinatal transmission of human immunodeficiency virus type 1 (HIV-1) should be determined to facilitate its use in areas where resources are limited.</p> <p>METHODS: We conducted a randomized, double-blind equivalence trial of zidovudine starting in the mother at 28 weeks' gestation, with 6 weeks of treatment in the infant (the long-long regimen), which is similar to protocol 076; zidovudine starting at 35 weeks' gestation, with 3 days of treatment in the infant (the short-short regimen); a long-short regimen; and a short-long regimen. The mothers received zidovudine orally during labor. The infants were fed formula and were tested for HIV DNA at 1, 45, 120, and 180 days. After the first interim analysis, the short-short regimen was stopped.</p> <p>RESULTS: A total of 1437 women were enrolled. At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long-long regimen and 10.5 percent for the short-short regimen (P=0.004). For the entire study period, the transmission rates were 6.5 percent (95 percent confidence interval, 4.1 to 8.9 percent) for the long-long regimen, 4.7 percent (95 percent confidence interval, 2.4 to 7.0 percent) for the long-short regimen, and 8.6 percent (95 percent confidence interval, 5.6 to 11.6 percent) for the short-long regimen. The rate of in utero transmission was significantly higher with the two regimens with shorter maternal treatment (5.1 percent) than with the two with longer maternal treatment (1.6 percent).</p> <p>CONCLUSIONS: The short-short zidovudine regimen is inferior to the long-long regimen and leads to a higher rate of perinatal HIV transmission. The long-short, short-long, and long-long regimens had equivalent efficacy. However, the higher rate of in utero transmission with the short-long regimen suggests that longer treatment of the infant cannot substitute for longer treatment of the mother.</p>
refterms.dateFOA2024-03-07T18:14:42Z
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
nejm200010053431401.pdf
Size:
173.37 KB
Format:
Adobe Portable Document Format
Description:
Download
Collections
UMass Chan Faculty and Researcher Publications