title: Increased risk of preterm delivery among HIV-infected women randomized to protease versus nucleoside reverse transcriptase inhibitor-based HAART during pregnancy.
abstract: BACKGROUND
  Protease inhibitor (PI)-based highly active antiretroviral therapy (HAART) use in pregnancy has been associated with preterm deliveries in some observational studies.
  
  
  METHODS
  HIV-infected, HAART-naive pregnant women with CD4+ counts ≥200 cells/mm(3) were randomized between 26 and 34 weeks gestation to lopinavir/ritonavir/zidovudine/lamivudine (PI group) or abacavir/zidovudine/lamivudine (NRTI group) in a clinical trial to prevent mother-to-child HIV transmission. Risk factors for preterm delivery (<37 weeks) and differences by randomization arm were evaluated for live infants by logistic regression.
  
  
  RESULTS
  Preterm delivery rates were higher among 267 women in the PI group than 263 women in the NRTI group (21.4% vs 11.8%, P = .003). PI-based HAART was the most significant risk factor for preterm delivery [odds ratio = 2.03, 95% confidence interval 1.26-3.27, P = .004]. Mean change in maternal body mass index (BMI) 1 month after HAART initiation was lower in the PI group (P < .001); however, this was not significantly associated with preterm delivery. Neither infant hospitalizations nor mortality through 6 months of life differed by maternal regimen.
  
  
  CONCLUSIONS
  PI-based HAART was associated with increased preterm delivery but not increased infant hospitalizations or mortality in a clinical trial setting. The association between PI use and lower increase in BMI in late pregnancy warrants further study.
authors.affiliation: Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital, Boston, Massachusetts 02114, USA. kpowis@partners.org
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Powis
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: Jean
authors.initials: J
authors.lastname: Leidner
authors.forename: Erik
authors.initials: E
authors.lastname: van Widenfelt
authors.forename: Claire
authors.initials: C
authors.lastname: Moffat
authors.forename: Sikhulile
authors.initials: S
authors.lastname: Moyo
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: Max
authors.initials: M
authors.lastname: Essex
authors.forename: Roger L
authors.initials: RL
authors.lastname: Shapiro
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000139:chemically induced*; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents; D011480:Protease Inhibitors