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 language | English (US) |
|---|---|
| Pages (from-to) | 181-188 |
| Number of pages | 8 |
| Journal | Journal of Infectious Diseases |
| Volume | 186 |
| Issue number | 2 |
| DOIs | |
| State | Published - Jul 15 2002 |
ASJC Scopus subject areas
- Immunology and Allergy
- Infectious Diseases
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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.; Sullivan, John L.; Dorenbaum, Alejandro; Mofenson, Lynne; Chaix, Marie Laure; Rouzioux, Christine; Bazin, Brigitte; Rekacewicz, Claire; Delfraissy, Jean Francois; Dorenbaum, Alejandro; Bazin, Brigitte; Bryson, Yvonne; Sublette, Nina; Delke, Isaac; Rathore, Mobeen; Estep, Scharla; Fiore, Simona; Newell, Marie Louise; Gigliotti, Maria; Maupin, Robert; Watts, Heather; Gonzalez-Garcia, Adolfo; Shannon, Maureen; Culnane, Mary; Cunningham-Schrader, Bethann; Mirochnick, Mark; Rathore, Mobeen; Delke, Isaac; Mitchell, Charles D.; Bryan, Patricia; Thorpe, Edwin; Sublette, Nina; Maupin, Robert; Alchediak, Thomas; Jimenez, Eleanor; Gandia, Jorge; Borkowsky, William; Minter, Maryam; Squires, Janet; Wendel, George; Shearer, William T.; Hammill, Hunter A.; Moore, Ellen; Jones, Theodore; Talero, Guillermo; Bliss, Winston O.; Pitt, Jane; Brown, Gina; Heyer, Ibef; Lugo, Lisette; Wara, Diane; Beckerman, Karen P.; Hull, Andrew D.; Spector, Stephen A.; Rana, Sohail; Dennis, Marilyn; Wilson, Gregory J.; Bender, Peggy; Yogev, Ram; Stanislawski, Donna; Bardeguez, Arlene; Grandchamp, Jocelyn; Kaufman, Gary; Kay, Laureen; Deville, Jaime; Dilllon, Maryanne; Tuomala, Ruth; Burchett, Sandra; Farley, John; Davis, Barbara; Rich, Kenneth C.; Vajaranant, Mark; Pathak, Indu; Khakoo, Hamida; Wade, Nancy; Samuelson, Renee; Boldman, Deb; Hitti, Jane; Deveikis, Audra; Melton, Lisa; Livingston, Elizabeth; Ferguson, Lori; Barr, Emily; Nosovitch, John; Stek, Alice; Kovacs, Andrea; Lavoie, Susanne R.; Smith, Tima Y.; Daniel, Pam; Kohler, Patricia; Keller, Margaret; Beall, Marie; Mc Farland, Elizabeth J.; Salbenblatt, Carol; Ranzini, Angela; Lake, Marian; Salazar, Juan C.; Campbell, Winston; Pass, Robert F.; Crain, Marilyn J.; Luzuriaga, Katherine; Noone, Sheila; Weinberg, Geoffrey A.; Laverty, Susan; Pitkin, Betsy; Lim, Wilma; Lancaster, Dan; Terry, Debra; Whiteman, Valerie E.; Tedaldi, Ellen M.; Sleasman, John; Duff, Patrick; Gay, Hannah; Boudreaux, Netta; Sha, Beverly E.; Davis, Ruth M.; Cintron, Hector; Figueroa, Wanda; Johnson, George; Wara, Diane; Shannon, Maureen; Wara, Diane; Shannon, Maureen; Gaur, Sunanda; Williams, Whitley; Levin, Myron J.; Weinberg, Adriana; Lischener, Harold W.; Hassey, Kelly R.; Watts, Heather; Mofenson, Lynne; Mayaux, Marie Jeanne; Blanche, Stephane; Rouzioux, Christine; Tardieu, Marc; Aboulker, Jean Pierre; Baumelou, Bertrand; Chambrin, Veronique; Razafimahefa, Hassina; Mandelbrot, Laurent; Firtion, Guislaine; Ciraru-Vigneron, Nicole; Bruner, Claudine; Berrebi, Alain; Hocke, Claude; Douard, Daniele; Crenn-Hebert, Catherine; Floch-Tulal, Corinne; Wilmer, Etienne; Ottenvalter, Annick; Khuong, Marie Aude; Retbi, Jean Marc; Jeantils, Vincent; Lachassine, Eric; Matheron, Sophie; Benifla, Jean Louis; Huraux-Rendu, Cristianne; Teboul, Joelle; Fried, Deborah; Heller-Roussin, Brigitte; Clavier, Brigitte; Brossard, Veronique; Bongain, Andre; Monpoux, Fabrice; Levardon, Michel; Mazy, Fabienne; Cayol, Veronique; Dolfus, Catherine; Benos, Paul; Nicolas, Joelle; Raudrant, Daniel; Cotte, Laurent; Francois, Cecile; Mechinaud, Francoise; Nguyen, Rose; May, Adrien; Mougeon, Benedicte; Devidas, Alain.
In: Journal of Infectious Diseases, Vol. 186, No. 2, 15.07.2002, p. 181-188.Research output: Contribution to journal › Article › peer-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 -