title: Haematological safety of perinatal zidovudine in pregnant HIV-1-infected women in Thailand: secondary analysis of a randomized trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis.
  
  
  METHODS
  27 hospitals in Thailand.
  
  
  METHODS
  1,436 HIV-infected pregnant women in PHPT-1.
  
  
  METHODS
  Zidovudine prophylaxis initiation at 28 or 35 wk gestation.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institut National d'Etudes Démographiques, Paris, France. nelly.briand@ined.fr
authors.forename: Nelly
authors.initials: N
authors.lastname: Briand
authors.forename: Marc
authors.initials: M
authors.lastname: Lallemant
authors.forename: Gonzague
authors.initials: G
authors.lastname: Jourdain
authors.forename: Somnuek
authors.initials: S
authors.lastname: Techapalokul
authors.forename: Preecha
authors.initials: P
authors.lastname: Tunthanathip
authors.forename: Surachet
authors.initials: S
authors.lastname: Suphanich
authors.forename: Truengta
authors.initials: T
authors.lastname: Chanpoo
authors.forename: Patrinee
authors.initials: P
authors.lastname: Traisathit
authors.forename: Kenneth
authors.initials: K
authors.lastname: McIntosh
authors.forename: Sophie
authors.initials: S
authors.lastname: Le Coeur