title: Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022.
abstract: OBJECTIVE
  To compare the safety of nelfinavir and nevirapine-based antiretroviral treatment in HIV-1-infected pregnant women.
  
  
  METHODS
  In Pediatric AIDS Clinical Trials Group Protocol 1022, 38 antiretroviral-naive pregnant women at 10-30 weeks' gestation were randomized to nelfinavir or nevirapine with zidovudine plus lamivudine. The study was suspended because of greater than expected toxicity and changes in nevirapine prescribing information. The incidence of treatment-limiting hepatic or cutaneous toxicity was compared between groups for all subjects and for the subset with CD4 cell counts greater than 250 cells/microL at study entry.
  
  
  RESULTS
  Toxicity was seen in 1 (5%) of 21 subjects randomized to nelfinavir and 5 (29%) of 17 subjects randomized to nevirapine (P = 0.07). Within the nevirapine group, 1 subject developed fulminant hepatic failure and died, and another developed Stevens-Johnson syndrome. The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL. All 5 events among subjects with a CD4 cell count greater than 250 cells/microL were associated with nevirapine (P = 0.04).
  
  
  CONCLUSIONS
  Continuous nevirapine may be associated with increased toxicity among HIV-1-infected pregnant women with CD4 cell counts greater than 250 cells/microL, as has been observed in non-pregnant women.
authors.affiliation: University of Washington, Seattle, 98195, USA. jhitti@u.washington.edu
authors.forename: Jane
authors.initials: J
authors.lastname: Hitti
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Frenkel
authors.forename: Alice M
authors.initials: AM
authors.lastname: Stek
authors.forename: Sharon A
authors.initials: SA
authors.lastname: Nachman
authors.forename: David
authors.initials: D
authors.lastname: Baker
authors.forename: Adolfo
authors.initials: A
authors.lastname: Gonzalez-Garcia
authors.forename: Arthur
authors.initials: A
authors.lastname: Provisor
authors.forename: Edwin M
authors.initials: EM
authors.lastname: Thorpe
authors.forename: Mary E
authors.initials: ME
authors.lastname: Paul
authors.forename: Marc
authors.initials: M
authors.lastname: Foca
authors.forename: Jorge
authors.initials: J
authors.lastname: Gandia
authors.forename: Sharon
authors.initials: S
authors.lastname: Huang
authors.forename: Lee-Jen
authors.initials: LJ
authors.lastname: Wei
authors.forename: Laura M
authors.initials: LM
authors.lastname: Stevens
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.forename: James
authors.initials: J
authors.lastname: McNamara
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007231:Infant, Newborn; D017114:Liver Failure, Acute / Q000139:chemically induced; D019888:Nelfinavir / Q000008:administration & dosage / Q000009:adverse effects; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000276:immunology; D012449:Safety; D013262:Stevens-Johnson Syndrome / Q000139:chemically induced
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine; D019888:Nelfinavir