Maternal toxicity with continuous nevirapine in pregnancy results from PACTG 1022

Jane Hitti, Lisa M. Frenkel, Alice M. Stek, Sharon A. Nachman, David Baker, Adolfo Gonzalez-Garcia, Arthur Provisor, Edwin M. Thorpe, Mary E. Paul, Marc Foca, Jorge Gandia, Sharon Huang, Lee Jen Wei, Laura M. Stevens, D. Heather Watts, James McNamara

Research output: Contribution to journalArticlepeer-review

137 Scopus citations


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/μL 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/μL. All 5 events among subjects with a CD4 cell count greater than 250 cells/μL 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/μL, as has been observed in nonpregnant women.

Original languageEnglish (US)
Pages (from-to)772-776
Number of pages5
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number3
StatePublished - Jul 1 2004
Externally publishedYes


  • Cutaneous toxicity
  • Hepatic toxicity
  • Nelfinavir
  • Nevirapine
  • Pregnancy

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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