title: HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana.
abstract: OBJECTIVE
  HAART for prevention of mother-to-child HIV transmission (MTCT) may impact long-term survival of women and children.
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  HIV-infected pregnant women with CD4+ cell count at least 200 cells/µl were randomly assigned to abacavir, zidovudine, lamivudine (arm A) or lopinavir–ritonavir, zidovudine–lamivudine (arm B) from week 26 to 34 gestation through planned weaning by 6 months postpartum. Women with baseline CD4+ cell count less than 200 cells/µl received nevirapine–zidovudine–lamivudine indefinitely (Obs arm), as did randomized women later qualifying for treatment.
  
  
  RESULTS
  Among 560 randomized and 170 observational women enrolled, there were 14 deaths (1.9%) – one antenatally (Obs), three from delivery to 6 months postpartum (1 arm A, 2 Obs), and 10 from 6 to 24 months postpartum (5 arm A, 3 arm B, 2 Obs). Time to death or CD4+ cell count below 200 cells/µl was shorter in arm A vs. B (P = 0.03). Of the 709 live-born children, 97% breastfed for a median of 5.8 months. Of 37 (5.2%) deaths by 24 months, nine were before breastfeeding initiated (3 arm A, 2 arm B, 4 Obs); six while breastfeeding (1 arm A, 2 arm B, 3 Obs); and 22 after weaning (9 arm A, 11 arm B, 2 Obs). Only eight children (1.1%) were HIV-infected at 24 months (6 arm A, 1 arm B, 1 Obs), all before 6 months.
  
  
  CONCLUSIONS
  Low MTCT was maintained through extended follow-up in all arms. Disease progression appeared slower after discontinuing protease inhibitor-based HAART, but a concerning number of maternal deaths occurred after stopping either regimen. Strategies to improve maternal and child survival in the postintervention period are required.
authors.forename: Roger L
authors.initials: RL
authors.lastname: Shapiro
authors.forename: Douglas
authors.initials: D
authors.lastname: Kitch
authors.forename: Anthony
authors.initials: A
authors.lastname: Ogwu
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hughes
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
authors.forename: Kathleen
authors.initials: K
authors.lastname: Powis
authors.forename: Sajini
authors.initials: S
authors.lastname: Souda
authors.forename: Claire
authors.initials: C
authors.lastname: Moffat
authors.forename: Sikhulile
authors.initials: S
authors.lastname: Moyo
authors.forename: Kenneth
authors.initials: K
authors.lastname: McIntosh
authors.forename: Erik
authors.initials: E
authors.lastname: van Widenfelt
authors.forename: Sheryl
authors.initials: S
authors.lastname: Zwerski
authors.forename: Loeto
authors.initials: L
authors.lastname: Mazhani
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: Max
authors.initials: M
authors.lastname: Essex
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D001902:Botswana; D001942:Breast Feeding; D002675:Child, Preschool; D005260:Female; D015658:HIV Infections / Q000401:mortality / Q000517:prevention & control* / Q000635:transmission*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents