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 3 (2022)

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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This output contributes to the following UN Sustainable Development Goals (SDGs)

  • 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 (1)

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Cunningham, C. K., Britto, P., Gelber, R. D., Sullivan, J. L., Dorenbaum, A., Mofenson, L., Chaix, M. L., Rouzioux, C., Bazin, B., Rekacewicz, C., Delfraissy, J. F., Dorenbaum, A., Bazin, B., Bryson, Y., Sublette, N., Delke, I., Rathore, M., Estep, S., Fiore, S., ... Devidas, A. (2002). 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. Journal of Infectious Diseases, 186(2), 181-188. https://doi.org/10.1086/341300

Cunningham, Coleen K. ; Britto, Paula ; Gelber, Richard D. et al. / 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. In: Journal of Infectious Diseases. 2002 ; Vol. 186, No. 2. pp. 181-188.

@article{8e6a1445ff0a4259af9bc16506227150,

title = "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",

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.",

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

note = "Funding Information: Financial support: Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases (National Institutes of Health [NIH] AI41110); National Institute of Child Health and Human Development (NIH AI32907 to J.L.S.); Center for AIDS Research at the University of Massachusetts Medical School (NIH AI42845); Agence Nationale de Recherches sur le SIDA (grant 083); Boehringer Ingelheim, France.",

year = "2002",

month = jul,

day = "15",

doi = "10.1086/341300",

language = "English (US)",

volume = "186",

pages = "181--188",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "2",

}

Cunningham, CK, Britto, P, Gelber, RD, Sullivan, JL, Dorenbaum, A, Mofenson, L, Chaix, ML, Rouzioux, C, Bazin, B, Rekacewicz, C, Delfraissy, JF, Dorenbaum, A, Bazin, B, Bryson, Y, Sublette, N, Delke, I, Rathore, M, Estep, S, Fiore, S, Newell, ML, Gigliotti, M, Maupin, R, Watts, H, Gonzalez-Garcia, A, Shannon, M, Culnane, M, Cunningham-Schrader, B, Mirochnick, M, Rathore, M, Delke, I, Mitchell, CD, Bryan, P, Thorpe, E, Sublette, N, Maupin, R, Alchediak, T, Jimenez, E, Gandia, J, Borkowsky, W, Minter, M, Squires, J, Wendel, G, Shearer, WT, Hammill, HA, Moore, E, Jones, T, Talero, G, Bliss, WO, Pitt, J, Brown, G, Heyer, I, Lugo, L, Wara, D, Beckerman, KP, Hull, AD, Spector, SA, Rana, S, Dennis, M, Wilson, GJ, Bender, P, Yogev, R, Stanislawski, D, Bardeguez, A, Grandchamp, J, Kaufman, G, Kay, L, Deville, J, Dilllon, M, Tuomala, R, Burchett, S, Farley, J, Davis, B, Rich, KC, Vajaranant, M, Pathak, I, Khakoo, H, Wade, N, Samuelson, R, Boldman, D, Hitti, J, Deveikis, A, Melton, L, Livingston, E, Ferguson, L, Barr, E, Nosovitch, J, Stek, A, Kovacs, A, Lavoie, SR, Smith, TY, Daniel, P, Kohler, P, Keller, M, Beall, M, Mc Farland, EJ, Salbenblatt, C, Ranzini, A, Lake, M, Salazar, JC, Campbell, W, Pass, RF, Crain, MJ, Luzuriaga, K, Noone, S, Weinberg, GA, Laverty, S, Pitkin, B, Lim, W, Lancaster, D, Terry, D, Whiteman, VE, Tedaldi, EM, Sleasman, J, Duff, P, Gay, H, Boudreaux, N, Sha, BE, Davis, RM, Cintron, H, Figueroa, W, Johnson, G, Wara, D, Shannon, M, Wara, D, Shannon, M, Gaur, S, Williams, W, Levin, MJ, Weinberg, A, Lischener, HW, Hassey, KR, Watts, H, Mofenson, L, Mayaux, MJ, Blanche, S, Rouzioux, C, Tardieu, M, Aboulker, JP, Baumelou, B, Chambrin, V, Razafimahefa, H, Mandelbrot, L, Firtion, G, Ciraru-Vigneron, N, Bruner, C, Berrebi, A, Hocke, C, Douard, D, Crenn-Hebert, C, Floch-Tulal, C, Wilmer, E, Ottenvalter, A, Khuong, MA, Retbi, JM, Jeantils, V, Lachassine, E, Matheron, S, Benifla, JL, Huraux-Rendu, C, Teboul, J, Fried, D, Heller-Roussin, B, Clavier, B, Brossard, V, Bongain, A, Monpoux, F, Levardon, M, Mazy, F, Cayol, V, Dolfus, C, Benos, P, Nicolas, J, Raudrant, D, Cotte, L, Francois, C, Mechinaud, F, Nguyen, R, May, A, Mougeon, B & Devidas, A 2002, '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', Journal of Infectious Diseases, vol. 186, no. 2, pp. 181-188. https://doi.org/10.1086/341300

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. / Cunningham, Coleen K.; Britto, Paula; Gelber, Richard D. et al.

In: Journal of Infectious Diseases, Vol. 186, No. 2, 15.07.2002, p. 181-188.

Research output: Contribution to journalArticlepeer-review

TY - JOUR

T1 - Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission

T2 - A substudy of pediatric aids clinical trials group protocol 316

AU - Cunningham, Coleen K.

AU - Britto, Paula

AU - Gelber, Richard D.

AU - Sullivan, John L.

AU - Dorenbaum, Alejandro

AU - Mofenson, Lynne

AU - Chaix, Marie Laure

AU - Rouzioux, Christine

AU - Bazin, Brigitte

AU - Rekacewicz, Claire

AU - Delfraissy, Jean Francois

AU - Dorenbaum, Alejandro

AU - Bazin, Brigitte

AU - Bryson, Yvonne

AU - Sublette, Nina

AU - Delke, Isaac

AU - Rathore, Mobeen

AU - Estep, Scharla

AU - Fiore, Simona

AU - Newell, Marie Louise

AU - Gigliotti, Maria

AU - Maupin, Robert

AU - Watts, Heather

AU - Gonzalez-Garcia, Adolfo

AU - Shannon, Maureen

AU - Culnane, Mary

AU - Cunningham-Schrader, Bethann

AU - Mirochnick, Mark

AU - Rathore, Mobeen

AU - Delke, Isaac

AU - Mitchell, Charles D.

AU - Bryan, Patricia

AU - Thorpe, Edwin

AU - Sublette, Nina

AU - Maupin, Robert

AU - Alchediak, Thomas

AU - Jimenez, Eleanor

AU - Gandia, Jorge

AU - Borkowsky, William

AU - Minter, Maryam

AU - Squires, Janet

AU - Wendel, George

AU - Shearer, William T.

AU - Hammill, Hunter A.

AU - Moore, Ellen

AU - Jones, Theodore

AU - Talero, Guillermo

AU - Bliss, Winston O.

AU - Pitt, Jane

AU - Brown, Gina

AU - Heyer, Ibef

AU - Lugo, Lisette

AU - Wara, Diane

AU - Beckerman, Karen P.

AU - Hull, Andrew D.

AU - Spector, Stephen A.

AU - Rana, Sohail

AU - Dennis, Marilyn

AU - Wilson, Gregory J.

AU - Bender, Peggy

AU - Yogev, Ram

AU - Stanislawski, Donna

AU - Bardeguez, Arlene

AU - Grandchamp, Jocelyn

AU - Kaufman, Gary

AU - Kay, Laureen

AU - Deville, Jaime

AU - Dilllon, Maryanne

AU - Tuomala, Ruth

AU - Burchett, Sandra

AU - Farley, John

AU - Davis, Barbara

AU - Rich, Kenneth C.

AU - Vajaranant, Mark

AU - Pathak, Indu

AU - Khakoo, Hamida

AU - Wade, Nancy

AU - Samuelson, Renee

AU - Boldman, Deb

AU - Hitti, Jane

AU - Deveikis, Audra

AU - Melton, Lisa

AU - Livingston, Elizabeth

AU - Ferguson, Lori

AU - Barr, Emily

AU - Nosovitch, John

AU - Stek, Alice

AU - Kovacs, Andrea

AU - Lavoie, Susanne R.

AU - Smith, Tima Y.

AU - Daniel, Pam

AU - Kohler, Patricia

AU - Keller, Margaret

AU - Beall, Marie

AU - Mc Farland, Elizabeth J.

AU - Salbenblatt, Carol

AU - Ranzini, Angela

AU - Lake, Marian

AU - Salazar, Juan C.

AU - Campbell, Winston

AU - Pass, Robert F.

AU - Crain, Marilyn J.

AU - Luzuriaga, Katherine

AU - Noone, Sheila

AU - Weinberg, Geoffrey A.

AU - Laverty, Susan

AU - Pitkin, Betsy

AU - Lim, Wilma

AU - Lancaster, Dan

AU - Terry, Debra

AU - Whiteman, Valerie E.

AU - Tedaldi, Ellen M.

AU - Sleasman, John

AU - Duff, Patrick

AU - Gay, Hannah

AU - Boudreaux, Netta

AU - Sha, Beverly E.

AU - Davis, Ruth M.

AU - Cintron, Hector

AU - Figueroa, Wanda

AU - Johnson, George

AU - Wara, Diane

AU - Shannon, Maureen

AU - Wara, Diane

AU - Shannon, Maureen

AU - Gaur, Sunanda

AU - Williams, Whitley

AU - Levin, Myron J.

AU - Weinberg, Adriana

AU - Lischener, Harold W.

AU - Hassey, Kelly R.

AU - Watts, Heather

AU - Mofenson, Lynne

AU - Mayaux, Marie Jeanne

AU - Blanche, Stephane

AU - Rouzioux, Christine

AU - Tardieu, Marc

AU - Aboulker, Jean Pierre

AU - Baumelou, Bertrand

AU - Chambrin, Veronique

AU - Razafimahefa, Hassina

AU - Mandelbrot, Laurent

AU - Firtion, Guislaine

AU - Ciraru-Vigneron, Nicole

AU - Bruner, Claudine

AU - Berrebi, Alain

AU - Hocke, Claude

AU - Douard, Daniele

AU - Crenn-Hebert, Catherine

AU - Floch-Tulal, Corinne

AU - Wilmer, Etienne

AU - Ottenvalter, Annick

AU - Khuong, Marie Aude

AU - Retbi, Jean Marc

AU - Jeantils, Vincent

AU - Lachassine, Eric

AU - Matheron, Sophie

AU - Benifla, Jean Louis

AU - Huraux-Rendu, Cristianne

AU - Teboul, Joelle

AU - Fried, Deborah

AU - Heller-Roussin, Brigitte

AU - Clavier, Brigitte

AU - Brossard, Veronique

AU - Bongain, Andre

AU - Monpoux, Fabrice

AU - Levardon, Michel

AU - Mazy, Fabienne

AU - Cayol, Veronique

AU - Dolfus, Catherine

AU - Benos, Paul

AU - Nicolas, Joelle

AU - Raudrant, Daniel

AU - Cotte, Laurent

AU - Francois, Cecile

AU - Mechinaud, Francoise

AU - Nguyen, Rose

AU - May, Adrien

AU - Mougeon, Benedicte

AU - Devidas, Alain

N1 - Funding Information:Financial support: Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases (National Institutes of Health [NIH] AI41110); National Institute of Child Health and Human Development (NIH AI32907 to J.L.S.); Center for AIDS Research at the University of Massachusetts Medical School (NIH AI42845); Agence Nationale de Recherches sur le SIDA (grant 083); Boehringer Ingelheim, France.

PY - 2002/7/15

Y1 - 2002/7/15

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0037099368&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037099368&partnerID=8YFLogxK

U2 - 10.1086/341300

DO - 10.1086/341300

M3 - Article

C2 - 12134253

AN - SCOPUS:0037099368

VL - 186

SP - 181

EP - 188

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 2

ER -

Cunningham CK, Britto P, Gelber RD, Sullivan JL, Dorenbaum A, Mofenson L et al. 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. Journal of Infectious Diseases. 2002 Jul 15;186(2):181-188. doi: 10.1086/341300

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