@article{fdi:010037979,
  title = {{H}aematological safety of perinatal zidovudine in pregnant {HIV}-1-infected women in {T}hailand: {S}econdary analysis of a randomized trial - art. no. e11},
  author = {{B}riand, {N}elly and {L}allemant, {M}arc and {J}ourdain, {G}onzague and {T}echapalokul, {S}omnuek and {T}unthanathip, {P}reecha and {S}uphanich, {S}urachet and {C}hanpoo, {T}ruengta and {T}raisathit, {P}atrinee and {M}c{I}ntosh, {K}. and {L}e {C}oeur, {S}ophie},
  abstract = {{O}bjectives: {T}o respond to the primary safety objective of the {P}erinatal {HIV} {P}revention {T}rial 1 ({PHPT}-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in {HIV}-1-infected pregnant women. {D}esign: {M}ulticenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. {S}etting: 27 hospitals in {T}hailand. {P}articipants: 1,436 {HIV}-infected pregnant women in {PHPT}-1. {I}ntervention: {Z}idovudine prophylaxis initiation at 28 or 35 wk gestation. {O}utcome measures: {H}aemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. {T}he 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. {F}or each parameter, linear mixed models were adjusted on baseline sociodemographic variables, {HIV} clinical stage, {CD}4 count, and viral load. {R}esults: {B}etween 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). {H}owever, 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). {A}t 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). {Z}idovudine had no negative impact on the absolute lymphocyte counts. {C}onclusion: {Z}idovudine 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. {T}his result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal {HIV}.},
  keywords = {},
  journal = {{P}los {C}linical {T}rials},
  volume = {2},
  numero = {4},
  pages = {{NIL}_1--{NIL}_8},
  ISSN = {1555-5887},
  year = {2007},
  DOI = {10.1371/journal.pctr.0020011},
  URL = {http://www.documentation.ird.fr/hor/fdi:010037979},
}