title: A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil.
abstract: OBJECTIVE
  To evaluate the safety and feasibility of zidovudine and lamivudine (AZT/3TC) given to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil.
  
  
  METHODS
  This open label phase II study enrolled 40 HIV infected antiretroviral naive women >or=20 weeks gestation, CD4 <500 cells x10(6)/l, from two public hospitals.
  
  
  METHODS
  fixed dose AZT 300 mg/3TC 150 mg by mouth every 12 hours until labour; AZT 300 mg by mouth every 3 hours until delivery; infants: AZT 4 mg/kg every 12 hours plus 3TC 2 mg/kg every 12 hours for 6 weeks. Blood haematology and chemistry were monitored; adherence evaluated by pills count; efficacy measured by changes in lymphocyte (CD4) and viral load, and by HIV RNA-PCR tests performed at birth, 6 and 12 weeks, to diagnose infant infection. No women breast fed.
  
  
  RESULTS
  
  
  
  METHODS
  mean age 24.48 (SD 3.5) years; gestational age 24.5 (4.5) weeks; AZT/3TC duration 14.4 (4.4) weeks; vaginal delivery: 11/39; caesarean section: 28/39. Entry and pre-labour CD4: 310/486 cells x10(6)/l (p<0.001); entry and pre-labour viral load: 53 818/2616 copies/ml (p<0.001). Thirty nine women tolerated treatment with >80% adherence; one was lost to follow up. Five newborns were excluded from 3TC receipt. All 39 babies were uninfected. Haematological toxicity in newborns was common: anaemia in 27; neutropenia in five (two severe); platelets counts <100000 in two. All values recovered on study completion.
  
  
  CONCLUSIONS
  Fixed dose AZT/3TC is well accepted, gives improvements in CD4 and viral load; no infants were HIV infected. Haematological toxicity in infants needs careful monitoring.
authors.affiliation: University of Maryland Institute of Human Virology, Baltimore, Maryland, USA. lambert@umbi.umd.edu
authors.forename: J S
authors.initials: JS
authors.lastname: Lambert
authors.forename: S A
authors.initials: SA
authors.lastname: Nogueira
authors.forename: T
authors.initials: T
authors.lastname: Abreu
authors.forename: E S
authors.initials: ES
authors.lastname: Machado
authors.forename: T P
authors.initials: TP
authors.lastname: Costa
authors.forename: M
authors.initials: M
authors.lastname: Bondarovsky
authors.forename: M
authors.initials: M
authors.lastname: Andrade
authors.forename: M
authors.initials: M
authors.lastname: Halpern
authors.forename: R
authors.initials: R
authors.lastname: Barbosa
authors.forename: M
authors.initials: M
authors.lastname: Perez
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D001938:Brazil; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D019259:Lamivudine / Q000008:administration & dosage*; D010865:Pilot Projects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D019562:Viral Load; D015215:Zidovudine / Q000008:administration & dosage*
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine