Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1–Infected Women in Thailand: Secondary Analysis of a Randomized Trial

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Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1–Infected Women in Thailand: Secondary Analysis of a Randomized Trial

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dc.contributor.author Briand, Nelly
dc.contributor.author Techapalokul, Somnuek
dc.contributor.author Tunthanathip, Preecha
dc.contributor.author Suphanich, Surachet
dc.contributor.author Chanpoo, Truengta
dc.contributor.author Traisathit, Patrinee
dc.contributor.author Coeur, Sophie Le
dc.contributor.author Lallemant, Marc Jean
dc.contributor.author Jourdain, Gonzague Joseph Albert
dc.contributor.author McIntosh, Kenneth
dc.date.accessioned 2011-05-18T23:55:49Z
dc.date.issued 2007
dc.identifier.citation Briand, Nelly, Marc Lallemant, Gonzague Jourdain, Somnuek Techapalokul, Preecha Tunthanathip, Surachet Suphanich, Truengta Chanpoo, Patrinee Traisathit, Kenneth McIntosh, and Sophie Le Coeur. 2007. Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1 - Infected Women in Thailand: Secondary Analysis of a Randomized Trial. PLoS Clinical Trials 2(4): e11. en_US
dc.identifier.issn 1555-5887 en_US
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:4891654
dc.description.abstract Objectives: To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1−infected pregnant women. Design: Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. Setting: 27 hospitals in Thailand.Participants: 1,436 HIV-infected pregnant women in PHPT-1.Intervention: Zidovudine prophylaxis initiation at 28 or 35 wk gestation. Outcome measures: Haemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. The evolution of haematological parameters was estimated between 26 and 35 wk (zidovudine/placebo) and between 35 wk and delivery to compare a long versus short zidovudine exposure. For each parameter, linear mixed models were adjusted on baseline sociodemographic variables, HIV clinical stage, CD4 count, and viral load. Results: Between 26 and 35 wk, haemoglobin, leucocytes, and absolute neutrophil counts decreased in zidovudine-exposed compared to unexposed women (mean difference [95% CI] −0.4 [−0.5 to −0.3], −423 [−703 to −142], −485 [−757 to −213], respectively). However, between 35 wk and delivery, the haematological parameters increased faster in women exposed to long rather than short durations of zidovudine (0.1 [0.0 to 0.1]; 105 [18 to 191]; 147 [59 to 234], respectively). At delivery, the differences were not statistically significant, except for mean haemoglobin level, which remained slightly lower in the long zidovudine treatment group (difference: 0.2 g/dl). Zidovudine had no negative impact on the absolute lymphocyte counts. Conclusion: Zidovudine initiated at 28 wk gestation rather than 35 wk had a transient negative impact on the evolution of haematological parameters, which was largely reversed by delivery despite continuation of zidovudine. This result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal HIV. en_US
dc.language.iso en_US en_US
dc.publisher Public Library of Science en_US
dc.relation.isversionof doi:10.1371/journal.pctr.0020011 en_US
dc.relation.hasversion http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1863515/pdf/ en_US
dash.license LAA
dc.subject infectious diseases en_US
dc.subject public health and epidemiology en_US
dc.subject women's health en_US
dc.title Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1–Infected Women in Thailand: Secondary Analysis of a Randomized Trial en_US
dc.type Journal Article en_US
dc.description.version Version of Record en_US
dc.relation.journal PLoS Clinical Trials en_US
dash.depositing.author Lallemant, Marc Jean
dc.date.available 2011-05-18T23:55:49Z
dash.affiliation.other SPH^Immunology and Infectious Diseases Thailand en_US
dash.affiliation.other SPH^Immunology and Infectious Diseases Thailand en_US
dash.affiliation.other SPH^Immunology and Infectious Diseases en_US
dash.affiliation.other HMS^Pediatrics-Children's Hospital en_US

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