Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359

Roy M. Gulick; X. Joan Hu; Susan A. Fiscus; Courtney V. Fletcher; Richard Haubrich; Hailong Cheng; Edward Acosta; Stephen W. Lagakos; Ronald Swanstrom; William Freimuth; Sally Snyder; Charlotte Mills; Margaret Fischl; Carla Pettinelli; David Katzenstein; Charles John Gonzalez; Olivia T. Ortiz; Richard Hutt; Candida T. Talabucon; Janine Maenza; Rebecca Becker; Dorcas Baker; Andrea Weiss; Robert Kalajian; Margaret Nelson; Kim Ingersol; Michael Saag; Sherree Wright; Tammy Powell; Pamposh Kaul; Donna Thee; Judith Feinberg; Joseph Wheat; Kristine Todd; Linda Meixner; Bruce Coon; Douglas Richman; Neel French; Joseph Pulvirenti; Harold Kessler; Jim Bruce; Aouie Carrera; Michael Borucki; John Fuchs; Karen Waterman; Joseph Eron; Charles Van der Horst; Linh Ngo; Janet Devine; M. Graham Ray; Beverly Putnam; Suzanne Fiorillo; John Gerber; Jane Norris; Debbie Slamowitz; Thomas Merigan; Harvey Friedman; Doris Shank; Chris Helker; Daniel Rodrigue; Frances Canchola; John M. Leedom; Liliana Aguinada; Scott A. Smith; Timothy Schacker; Henry Sacks; Alice Mercado; Hilda Mendoza; Steve Nowling; David Pearson; Laura Ponticello; Michael Giordano; Brenda Greenhill; Jorge L. Santana; Guillermo Vazquez; Ileana Lopez; Virginia Ramirez; Mary Albrecht; Don Craven; Andrea Christopher Belschner; Michael F. Para; Robert J. Fass; Jan Clark; Charles B. Hicks; Paulette Mac Dougall; Stuart Carr; Mary Shoemaker; Ross Hewitt; Susan Cohn; Juan J.L. Lertora; Mark Beilke; David Mushatt; Russell Strada; Gildon Beall; Dena Duran; Mario Guerrero; Mark A. Jacobson; Judy Aberg; Glenna Auerback; Phyllis Barnett; Pablo Tebas; Genice Hamilton; Michael Royal; Lyle Oshita; Monica Millard; Scott Souza; Debra Ogata-Arakaki; Robert Delapenha; John Mc Neil; Lisa Alexis; Judith Brown; Elizabeth Gimbel; Ann Walawander; Kenneth Wood; Jeff Taylor; Bruce Peel; Jon Cook; Carol Brosgart; James Rooney; Cheryl Karol; Pascal De Caprariis; Jeanne Berg; Margo Heath-Chiozzi; Eugene Sun; Mark Becker; Ana Martinez; Robin Shepard; Melissa Kerkau; Joan Dragavon; Michelle Jack; Vivian Yuan; Robert Coombs; Antoinette Kenton; Sharon Shriver; Hongyu Jiang

doi:10.1086/342681

Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359

Roy M. Gulick, X. Joan Hu, Susan A. Fiscus, Courtney V. Fletcher, Richard Haubrich, Hailong Cheng, Edward Acosta, Stephen W. Lagakos, Ronald Swanstrom, William Freimuth, Sally Snyder, Charlotte Mills, Margaret Fischl, Carla Pettinelli, David Katzenstein, Charles John Gonzalez, Olivia T. Ortiz, Richard Hutt, Candida T. Talabucon, Janine MaenzaRebecca Becker, Dorcas Baker, Andrea Weiss, Robert Kalajian, Margaret Nelson, Kim Ingersol, Michael Saag, Sherree Wright, Tammy Powell, Pamposh Kaul, Donna Thee, Judith Feinberg, Joseph Wheat, Kristine Todd, Linda Meixner, Bruce Coon, Douglas Richman, Neel French, Joseph Pulvirenti, Harold Kessler, Jim Bruce, Aouie Carrera, Michael Borucki, John Fuchs, Karen Waterman, Joseph Eron, Charles Van der Horst, Linh Ngo, Janet Devine, M. Graham Ray, Beverly Putnam, Suzanne Fiorillo, John Gerber, Jane Norris, Debbie Slamowitz, Thomas Merigan, Harvey Friedman, Doris Shank, Chris Helker, Daniel Rodrigue, Frances Canchola, John M. Leedom, Liliana Aguinada, Scott A. Smith, Timothy Schacker, Henry Sacks, Alice Mercado, Hilda Mendoza, Steve Nowling, David Pearson, Laura Ponticello, Michael Giordano, Brenda Greenhill, Jorge L. Santana, Guillermo Vazquez, Ileana Lopez, Virginia Ramirez, Mary Albrecht, Don Craven, Andrea Christopher Belschner, Michael F. Para, Robert J. Fass, Jan Clark, Charles B. Hicks, Paulette Mac Dougall, Stuart Carr, Mary Shoemaker, Ross Hewitt, Susan Cohn, Juan J.L. Lertora, Mark Beilke, David Mushatt, Russell Strada, Gildon Beall, Dena Duran, Mario Guerrero, Mark A. Jacobson, Judy Aberg, Glenna Auerback, Phyllis Barnett, Pablo Tebas, Genice Hamilton, Michael Royal, Lyle Oshita, Monica Millard, Scott Souza, Debra Ogata-Arakaki, Robert Delapenha, John Mc Neil, Lisa Alexis, Judith Brown, Elizabeth Gimbel, Ann Walawander, Kenneth Wood, Jeff Taylor, Bruce Peel, Jon Cook, Carol Brosgart, James Rooney, Cheryl Karol, Pascal De Caprariis, Jeanne Berg, Margo Heath-Chiozzi, Eugene Sun, Mark Becker, Ana Martinez, Robin Shepard, Melissa Kerkau, Joan Dragavon, Michelle Jack, Vivian Yuan, Robert Coombs, Antoinette Kenton, Sharon Shriver, Hongyu Jiang

Medicine, Infectious Diseases Division

Research output: Contribution to journal › Article › peer-review

11 Scopus citations

Abstract

The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)-infected, indinavir-experienced patients, was designed to study the durability of "salvage" treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12-16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels ≤500 copies/mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm³. Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens.

Original language	English (US)
Pages (from-to)	626-633
Number of pages	8
Journal	Journal of Infectious Diseases
Volume	186
Issue number	5
DOIs	https://doi.org/10.1086/342681
State	Published - Sep 1 2002

ASJC Scopus subject areas

Immunology and Allergy
Infectious Diseases

UN SDGs

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

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10.1086/342681

Cite this

Gulick, R. M., Hu, X. J., Fiscus, S. A., Fletcher, C. V., Haubrich, R., Cheng, H., Acosta, E., Lagakos, S. W., Swanstrom, R., Freimuth, W., Snyder, S., Mills, C., Fischl, M., Pettinelli, C., Katzenstein, D., Gonzalez, C. J., Ortiz, O. T., Hutt, R., Talabucon, C. T., ... Jiang, H. (2002). Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359. Journal of Infectious Diseases, 186(5), 626-633. https://doi.org/10.1086/342681

@article{667896b1f096451e8879671fdf655c70,

title = "Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359",

abstract = "The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)-infected, indinavir-experienced patients, was designed to study the durability of {"}salvage{"} treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12-16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels ≤500 copies/mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm3. Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens.",

author = "Gulick, {Roy M.} and Hu, {X. Joan} and Fiscus, {Susan A.} and Fletcher, {Courtney V.} and Richard Haubrich and Hailong Cheng and Edward Acosta and Lagakos, {Stephen W.} and Ronald Swanstrom and William Freimuth and Sally Snyder and Charlotte Mills and Margaret Fischl and Carla Pettinelli and David Katzenstein and Gonzalez, {Charles John} and Ortiz, {Olivia T.} and Richard Hutt and Talabucon, {Candida T.} and Janine Maenza and Rebecca Becker and Dorcas Baker and Andrea Weiss and Robert Kalajian and Margaret Nelson and Kim Ingersol and Michael Saag and Sherree Wright and Tammy Powell and Pamposh Kaul and Donna Thee and Judith Feinberg and Joseph Wheat and Kristine Todd and Linda Meixner and Bruce Coon and Douglas Richman and Neel French and Joseph Pulvirenti and Harold Kessler and Jim Bruce and Aouie Carrera and Michael Borucki and John Fuchs and Karen Waterman and Joseph Eron and {Van der Horst}, Charles and Linh Ngo and Janet Devine and Ray, {M. Graham} and Beverly Putnam and Suzanne Fiorillo and John Gerber and Jane Norris and Debbie Slamowitz and Thomas Merigan and Harvey Friedman and Doris Shank and Chris Helker and Daniel Rodrigue and Frances Canchola and Leedom, {John M.} and Liliana Aguinada and Smith, {Scott A.} and Timothy Schacker and Henry Sacks and Alice Mercado and Hilda Mendoza and Steve Nowling and David Pearson and Laura Ponticello and Michael Giordano and Brenda Greenhill and Santana, {Jorge L.} and Guillermo Vazquez and Ileana Lopez and Virginia Ramirez and Mary Albrecht and Don Craven and Belschner, {Andrea Christopher} and Para, {Michael F.} and Fass, {Robert J.} and Jan Clark and Hicks, {Charles B.} and {Mac Dougall}, Paulette and Stuart Carr and Mary Shoemaker and Ross Hewitt and Susan Cohn and Lertora, {Juan J.L.} and Mark Beilke and David Mushatt and Russell Strada and Gildon Beall and Dena Duran and Mario Guerrero and Jacobson, {Mark A.} and Judy Aberg and Glenna Auerback and Phyllis Barnett and Pablo Tebas and Genice Hamilton and Michael Royal and Lyle Oshita and Monica Millard and Scott Souza and Debra Ogata-Arakaki and Robert Delapenha and {Mc Neil}, John and Lisa Alexis and Judith Brown and Elizabeth Gimbel and Ann Walawander and Kenneth Wood and Jeff Taylor and Bruce Peel and Jon Cook and Carol Brosgart and James Rooney and Cheryl Karol and {De Caprariis}, Pascal and Jeanne Berg and Margo Heath-Chiozzi and Eugene Sun and Mark Becker and Ana Martinez and Robin Shepard and Melissa Kerkau and Joan Dragavon and Michelle Jack and Vivian Yuan and Robert Coombs and Antoinette Kenton and Sharon Shriver and Hongyu Jiang",

note = "Funding Information: R.M.G. received research grants from Abbott and Merck and speaker honoraria from Merck and served as an ad hoc consultant for Bristol-Myers, GlaxoSmithKline, and ViroLogic. S.F. received research grants and a speaker honorarium from GlaxoSmithKline. R.H. received research grant support and occasional speaker honoraria from Agouron, GlaxoSmithKline, Vertex, and ViroLogic. R.S. received a research grant from GlaxoSmithKline.",

year = "2002",

month = sep,

day = "1",

doi = "10.1086/342681",

language = "English (US)",

volume = "186",

pages = "626--633",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "5",

}

Gulick, RM, Hu, XJ, Fiscus, SA, Fletcher, CV, Haubrich, R, Cheng, H, Acosta, E, Lagakos, SW, Swanstrom, R, Freimuth, W, Snyder, S, Mills, C, Fischl, M, Pettinelli, C, Katzenstein, D, Gonzalez, CJ, Ortiz, OT, Hutt, R, Talabucon, CT, Maenza, J, Becker, R, Baker, D, Weiss, A, Kalajian, R, Nelson, M, Ingersol, K, Saag, M, Wright, S, Powell, T, Kaul, P, Thee, D, Feinberg, J, Wheat, J, Todd, K, Meixner, L, Coon, B, Richman, D, French, N, Pulvirenti, J, Kessler, H, Bruce, J, Carrera, A, Borucki, M, Fuchs, J, Waterman, K, Eron, J, Van der Horst, C, Ngo, L, Devine, J, Ray, MG, Putnam, B, Fiorillo, S, Gerber, J, Norris, J, Slamowitz, D, Merigan, T, Friedman, H, Shank, D, Helker, C, Rodrigue, D, Canchola, F, Leedom, JM, Aguinada, L, Smith, SA, Schacker, T, Sacks, H, Mercado, A, Mendoza, H, Nowling, S, Pearson, D, Ponticello, L, Giordano, M, Greenhill, B, Santana, JL, Vazquez, G, Lopez, I, Ramirez, V, Albrecht, M, Craven, D, Belschner, AC, Para, MF, Fass, RJ, Clark, J, Hicks, CB, Mac Dougall, P, Carr, S, Shoemaker, M, Hewitt, R, Cohn, S, Lertora, JJL, Beilke, M, Mushatt, D, Strada, R, Beall, G, Duran, D, Guerrero, M, Jacobson, MA, Aberg, J, Auerback, G, Barnett, P, Tebas, P, Hamilton, G, Royal, M, Oshita, L, Millard, M, Souza, S, Ogata-Arakaki, D, Delapenha, R, Mc Neil, J, Alexis, L, Brown, J, Gimbel, E, Walawander, A, Wood, K, Taylor, J, Peel, B, Cook, J, Brosgart, C, Rooney, J, Karol, C, De Caprariis, P, Berg, J, Heath-Chiozzi, M, Sun, E, Becker, M, Martinez, A, Shepard, R, Kerkau, M, Dragavon, J, Jack, M, Yuan, V, Coombs, R, Kenton, A, Shriver, S & Jiang, H 2002, 'Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359', Journal of Infectious Diseases, vol. 186, no. 5, pp. 626-633. https://doi.org/10.1086/342681

TY - JOUR

T1 - Durability of response to treatment among antiretroviral-experienced subjects

T2 - 48-Week results from AIDS Clinical Trials Group Protocol 359

AU - Gulick, Roy M.

AU - Hu, X. Joan

AU - Fiscus, Susan A.

AU - Fletcher, Courtney V.

AU - Haubrich, Richard

AU - Cheng, Hailong

AU - Acosta, Edward

AU - Lagakos, Stephen W.

AU - Swanstrom, Ronald

AU - Freimuth, William

AU - Snyder, Sally

AU - Mills, Charlotte

AU - Fischl, Margaret

AU - Pettinelli, Carla

AU - Katzenstein, David

AU - Gonzalez, Charles John

AU - Ortiz, Olivia T.

AU - Hutt, Richard

AU - Talabucon, Candida T.

AU - Maenza, Janine

AU - Becker, Rebecca

AU - Baker, Dorcas

AU - Weiss, Andrea

AU - Kalajian, Robert

AU - Nelson, Margaret

AU - Ingersol, Kim

AU - Saag, Michael

AU - Wright, Sherree

AU - Powell, Tammy

AU - Kaul, Pamposh

AU - Thee, Donna

AU - Feinberg, Judith

AU - Wheat, Joseph

AU - Todd, Kristine

AU - Meixner, Linda

AU - Coon, Bruce

AU - Richman, Douglas

AU - French, Neel

AU - Pulvirenti, Joseph

AU - Kessler, Harold

AU - Bruce, Jim

AU - Carrera, Aouie

AU - Borucki, Michael

AU - Fuchs, John

AU - Waterman, Karen

AU - Eron, Joseph

AU - Van der Horst, Charles

AU - Ngo, Linh

AU - Devine, Janet

AU - Ray, M. Graham

AU - Putnam, Beverly

AU - Fiorillo, Suzanne

AU - Gerber, John

AU - Norris, Jane

AU - Slamowitz, Debbie

AU - Merigan, Thomas

AU - Friedman, Harvey

AU - Shank, Doris

AU - Helker, Chris

AU - Rodrigue, Daniel

AU - Canchola, Frances

AU - Leedom, John M.

AU - Aguinada, Liliana

AU - Smith, Scott A.

AU - Schacker, Timothy

AU - Sacks, Henry

AU - Mercado, Alice

AU - Mendoza, Hilda

AU - Nowling, Steve

AU - Pearson, David

AU - Ponticello, Laura

AU - Giordano, Michael

AU - Greenhill, Brenda

AU - Santana, Jorge L.

AU - Vazquez, Guillermo

AU - Lopez, Ileana

AU - Ramirez, Virginia

AU - Albrecht, Mary

AU - Craven, Don

AU - Belschner, Andrea Christopher

AU - Para, Michael F.

AU - Fass, Robert J.

AU - Clark, Jan

AU - Hicks, Charles B.

AU - Mac Dougall, Paulette

AU - Carr, Stuart

AU - Shoemaker, Mary

AU - Hewitt, Ross

AU - Cohn, Susan

AU - Lertora, Juan J.L.

AU - Beilke, Mark

AU - Mushatt, David

AU - Strada, Russell

AU - Beall, Gildon

AU - Duran, Dena

AU - Guerrero, Mario

AU - Jacobson, Mark A.

AU - Aberg, Judy

AU - Auerback, Glenna

AU - Barnett, Phyllis

AU - Tebas, Pablo

AU - Hamilton, Genice

AU - Royal, Michael

AU - Oshita, Lyle

AU - Millard, Monica

AU - Souza, Scott

AU - Ogata-Arakaki, Debra

AU - Delapenha, Robert

AU - Mc Neil, John

AU - Alexis, Lisa

AU - Brown, Judith

AU - Gimbel, Elizabeth

AU - Walawander, Ann

AU - Wood, Kenneth

AU - Taylor, Jeff

AU - Peel, Bruce

AU - Cook, Jon

AU - Brosgart, Carol

AU - Rooney, James

AU - Karol, Cheryl

AU - De Caprariis, Pascal

AU - Berg, Jeanne

AU - Heath-Chiozzi, Margo

AU - Sun, Eugene

AU - Becker, Mark

AU - Martinez, Ana

AU - Shepard, Robin

AU - Kerkau, Melissa

AU - Dragavon, Joan

AU - Jack, Michelle

AU - Yuan, Vivian

AU - Coombs, Robert

AU - Kenton, Antoinette

AU - Shriver, Sharon

AU - Jiang, Hongyu

N1 - Funding Information: R.M.G. received research grants from Abbott and Merck and speaker honoraria from Merck and served as an ad hoc consultant for Bristol-Myers, GlaxoSmithKline, and ViroLogic. S.F. received research grants and a speaker honorarium from GlaxoSmithKline. R.H. received research grant support and occasional speaker honoraria from Agouron, GlaxoSmithKline, Vertex, and ViroLogic. R.S. received a research grant from GlaxoSmithKline.

PY - 2002/9/1

Y1 - 2002/9/1

N2 - The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)-infected, indinavir-experienced patients, was designed to study the durability of "salvage" treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12-16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels ≤500 copies/mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm3. Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens.

AB - The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)-infected, indinavir-experienced patients, was designed to study the durability of "salvage" treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12-16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels ≤500 copies/mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm3. Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens.

UR - http://www.scopus.com/inward/record.url?scp=0036720473&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036720473&partnerID=8YFLogxK

U2 - 10.1086/342681

DO - 10.1086/342681

M3 - Article

C2 - 12195349

AN - SCOPUS:0036720473

SN - 0022-1899

VL - 186

SP - 626

EP - 633

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

IS - 5

ER -

Durability of response to treatment among antiretroviral-experienced subjects: 48-Week results from AIDS Clinical Trials Group Protocol 359

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ASJC Scopus subject areas

UN SDGs

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