Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: A substudy of pediatric aids clinical trials group protocol 316

Coleen K. Cunningham, Paula Britto, Richard D. Gelber, John L. Sullivan, Alejandro Dorenbaum, Lynne Mofenson, Marie Laure Chaix, Christine Rouzioux, Brigitte Bazin, Claire Rekacewicz, Jean Francois Delfraissy, Alejandro Dorenbaum, Brigitte Bazin, Yvonne Bryson, Nina Sublette, Isaac Delke, Mobeen Rathore, Scharla Estep, Simona Fiore, Marie Louise NewellMaria Gigliotti, Robert Maupin, Heather Watts, Adolfo Gonzalez-Garcia, Maureen Shannon, Mary Culnane, Bethann Cunningham-Schrader, Mark Mirochnick, Mobeen Rathore, Isaac Delke, Charles D. Mitchell, Patricia Bryan, Edwin Thorpe, Nina Sublette, Robert Maupin, Thomas Alchediak, Eleanor Jimenez, Jorge Gandia, William Borkowsky, Maryam Minter, Janet Squires, George Wendel, William T. Shearer, Hunter A. Hammill, Ellen Moore, Theodore Jones, Guillermo Talero, Winston O. Bliss, Jane Pitt, Gina Brown, Ibef Heyer, Lisette Lugo, Diane Wara, Karen P. Beckerman, Andrew D. Hull, Stephen A. Spector, Sohail Rana, Marilyn Dennis, Gregory J. Wilson, Peggy Bender, Ram Yogev, Donna Stanislawski, Arlene Bardeguez, Jocelyn Grandchamp, Gary Kaufman, Laureen Kay, Jaime Deville, Maryanne Dilllon, Ruth Tuomala, Sandra Burchett, John Farley, Barbara Davis, Kenneth C. Rich, Mark Vajaranant, Indu Pathak, Hamida Khakoo, Nancy Wade, Renee Samuelson, Deb Boldman, Jane Hitti, Audra Deveikis, Lisa Melton, Elizabeth Livingston, Lori Ferguson, Emily Barr, John Nosovitch, Alice Stek, Andrea Kovacs, Susanne R. Lavoie, Tima Y. Smith, Pam Daniel, Patricia Kohler, Margaret Keller, Marie Beall, Elizabeth J. Mc Farland, Carol Salbenblatt, Angela Ranzini, Marian Lake, Juan C. Salazar, Winston Campbell, Robert F. Pass, Marilyn J. Crain, Katherine Luzuriaga, Sheila Noone, Geoffrey A. Weinberg, Susan Laverty, Betsy Pitkin, Wilma Lim, Dan Lancaster, Debra Terry, Valerie E. Whiteman, Ellen M. Tedaldi, John Sleasman, Patrick Duff, Hannah Gay, Netta Boudreaux, Beverly E. Sha, Ruth M. Davis, Hector Cintron, Wanda Figueroa, George Johnson, Diane Wara, Maureen Shannon, Diane Wara, Maureen Shannon, Sunanda Gaur, Whitley Williams, Myron J. Levin, Adriana Weinberg, Harold W. Lischener, Kelly R. Hassey, Heather Watts, Lynne Mofenson, Marie Jeanne Mayaux, Stephane Blanche, Christine Rouzioux, Marc Tardieu, Jean Pierre Aboulker, Bertrand Baumelou, Veronique Chambrin, Hassina Razafimahefa, Laurent Mandelbrot, Guislaine Firtion, Nicole Ciraru-Vigneron, Claudine Bruner, Alain Berrebi, Claude Hocke, Daniele Douard, Catherine Crenn-Hebert, Corinne Floch-Tulal, Etienne Wilmer, Annick Ottenvalter, Marie Aude Khuong, Jean Marc Retbi, Vincent Jeantils, Eric Lachassine, Sophie Matheron, Jean Louis Benifla, Cristianne Huraux-Rendu, Joelle Teboul, Deborah Fried, Brigitte Heller-Roussin, Brigitte Clavier, Veronique Brossard, Andre Bongain, Fabrice Monpoux, Michel Levardon, Fabienne Mazy, Veronique Cayol, Catherine Dolfus, Paul Benos, Joelle Nicolas, Daniel Raudrant, Laurent Cotte, Cecile Francois, Francoise Mechinaud, Rose Nguyen, Adrien May, Benedicte Mougeon, Alain Devidas

Research output: Contribution to journalArticlepeer-review

109 Scopus citations

Abstract

Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)-infected pregnant women receiving standard antiretroviral therapy. This substudy evaluated the emergence of nevirapine-resistance mutations at 6 weeks postpartum in a subgroup of participants. Maternal risk factors for the emergence of nevirapine-resistance mutations were evaluated. Mutations associated with nevirapine resistance were detectable at delivery, prior to receipt of study drug, in 5 (2.3%) of 217 women. Fourteen (15%; 95% confidence interval, 8%-23%) of 95 women who received intrapartum nevirapine developed a nevirapine-resistance mutation 6 weeks postpartum. The most common mutation was K103N, which was present in 10 women. The risk for development of a new nevirapine-resistance mutation did not correlate with CD4 cell count or HIV-1 RNA load at delivery or with type of antepartum antiretroviral therapy. The risk of nevirapine resistance should be considered when determining the risks or benefits of intrapartum nevirapine in women receiving antepartum antiretroviral therapy.

Original languageEnglish (US)
Pages (from-to)181-188
Number of pages8
JournalJournal of Infectious Diseases
Volume186
Issue number2
DOIs
StatePublished - Jul 15 2002

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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