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

Research output: Contribution to journalArticle

11 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)626-633
Number of pages8
JournalJournal of Infectious Diseases
Volume186
Issue number5
DOIs
StatePublished - Sep 1 2002

Fingerprint

Clinical Protocols
Acquired Immunodeficiency Syndrome
Clinical Trials
Saquinavir
Indinavir
CD4 Lymphocyte Count
Delavirdine
HIV
Nelfinavir
Ritonavir
Salvage Therapy
Therapeutics
Treatment Failure
Body Weight
RNA

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Durability of response to treatment among antiretroviral-experienced subjects : 48-Week results from AIDS Clinical Trials Group Protocol 359. / Gulick, Roy M.; Hu, X. Joan; Fiscus, Susan A.; Fletcher, Courtney V.; Haubrich, Richard; Cheng, Hailong; Acosta, Edward; Lagakos, Stephen W.; Swanstrom, Ronald; Freimuth, William; Snyder, Sally; Mills, Charlotte; Fischl, Margaret; Pettinelli, Carla; Katzenstein, David; Gonzalez, Charles John; Ortiz, Olivia T.; Hutt, Richard; Talabucon, Candida T.; Maenza, Janine; Becker, Rebecca; Baker, Dorcas; Weiss, Andrea; Kalajian, Robert; Nelson, Margaret; Ingersol, Kim; Saag, Michael; Wright, Sherree; Powell, Tammy; Kaul, Pamposh; Thee, Donna; Feinberg, Judith; Wheat, Joseph; Todd, Kristine; Meixner, Linda; Coon, Bruce; Richman, Douglas; French, Neel; Pulvirenti, Joseph; Kessler, Harold; Bruce, Jim; Carrera, Aouie; Borucki, Michael; Fuchs, John; Waterman, Karen; Eron, Joseph; Van der Horst, Charles; Ngo, Linh; Devine, Janet; Ray, M. Graham; Putnam, Beverly; Fiorillo, Suzanne; Gerber, John; Norris, Jane; Slamowitz, Debbie; Merigan, Thomas; Friedman, Harvey; Shank, Doris; Helker, Chris; Rodrigue, Daniel; Canchola, Frances; Leedom, John M.; Aguinada, Liliana; Smith, Scott A.; Schacker, Timothy; Sacks, Henry; Mercado, Alice; Mendoza, Hilda; Nowling, Steve; Pearson, David; Ponticello, Laura; Giordano, Michael; Greenhill, Brenda; Santana, Jorge L.; Vazquez, Guillermo; Lopez, Ileana; Ramirez, Virginia; Albrecht, Mary; Craven, Don; Belschner, Andrea Christopher; Para, Michael F.; Fass, Robert J.; Clark, Jan; Hicks, Charles B.; Mac Dougall, Paulette; Carr, Stuart; Shoemaker, Mary; Hewitt, Ross; Cohn, Susan; Lertora, Juan J.L.; Beilke, Mark; Mushatt, David; Strada, Russell; Beall, Gildon; Duran, Dena; Guerrero, Mario; Jacobson, Mark A.; Aberg, Judy; Auerback, Glenna; Barnett, Phyllis; Tebas, Pablo; Hamilton, Genice; Royal, Michael; Oshita, Lyle; Millard, Monica; Souza, Scott; Ogata-Arakaki, Debra; Delapenha, Robert; Mc Neil, John; Alexis, Lisa; Brown, Judith; Gimbel, Elizabeth; Walawander, Ann; Wood, Kenneth; Taylor, Jeff; Peel, Bruce; Cook, Jon; Brosgart, Carol; Rooney, James; Karol, Cheryl; De Caprariis, Pascal; Berg, Jeanne; Heath-Chiozzi, Margo; Sun, Eugene; Becker, Mark; Martinez, Ana; Shepard, Robin; Kerkau, Melissa; Dragavon, Joan; Jack, Michelle; Yuan, Vivian; Coombs, Robert; Kenton, Antoinette; Shriver, Sharon; Jiang, Hongyu.

In: Journal of Infectious Diseases, Vol. 186, No. 5, 01.09.2002, p. 626-633.

Research output: Contribution to journalArticle

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
Gulick, Roy M. ; Hu, X. Joan ; Fiscus, Susan A. ; Fletcher, Courtney V. ; Haubrich, Richard ; Cheng, Hailong ; Acosta, Edward ; Lagakos, Stephen W. ; Swanstrom, Ronald ; Freimuth, William ; Snyder, Sally ; Mills, Charlotte ; Fischl, Margaret ; Pettinelli, Carla ; Katzenstein, David ; Gonzalez, Charles John ; Ortiz, Olivia T. ; Hutt, Richard ; Talabucon, Candida T. ; Maenza, Janine ; Becker, Rebecca ; Baker, Dorcas ; Weiss, Andrea ; Kalajian, Robert ; Nelson, Margaret ; Ingersol, Kim ; Saag, Michael ; Wright, Sherree ; Powell, Tammy ; Kaul, Pamposh ; Thee, Donna ; Feinberg, Judith ; Wheat, Joseph ; Todd, Kristine ; Meixner, Linda ; Coon, Bruce ; Richman, Douglas ; French, Neel ; Pulvirenti, Joseph ; Kessler, Harold ; Bruce, Jim ; Carrera, Aouie ; Borucki, Michael ; Fuchs, John ; Waterman, Karen ; Eron, Joseph ; Van der Horst, Charles ; Ngo, Linh ; Devine, Janet ; Ray, M. Graham ; Putnam, Beverly ; Fiorillo, Suzanne ; Gerber, John ; Norris, Jane ; Slamowitz, Debbie ; Merigan, Thomas ; Friedman, Harvey ; Shank, Doris ; Helker, Chris ; Rodrigue, Daniel ; Canchola, Frances ; Leedom, John M. ; Aguinada, Liliana ; Smith, Scott A. ; Schacker, Timothy ; Sacks, Henry ; Mercado, Alice ; Mendoza, Hilda ; Nowling, Steve ; Pearson, David ; Ponticello, Laura ; Giordano, Michael ; Greenhill, Brenda ; Santana, Jorge L. ; Vazquez, Guillermo ; Lopez, Ileana ; Ramirez, Virginia ; Albrecht, Mary ; Craven, Don ; Belschner, Andrea Christopher ; Para, Michael F. ; Fass, Robert J. ; Clark, Jan ; Hicks, Charles B. ; Mac Dougall, Paulette ; Carr, Stuart ; Shoemaker, Mary ; Hewitt, Ross ; Cohn, Susan ; Lertora, Juan J.L. ; Beilke, Mark ; Mushatt, David ; Strada, Russell ; Beall, Gildon ; Duran, Dena ; Guerrero, Mario ; Jacobson, Mark A. ; Aberg, Judy ; Auerback, Glenna ; Barnett, Phyllis ; Tebas, Pablo ; Hamilton, Genice ; Royal, Michael ; Oshita, Lyle ; Millard, Monica ; Souza, Scott ; Ogata-Arakaki, Debra ; Delapenha, Robert ; Mc Neil, John ; Alexis, Lisa ; Brown, Judith ; Gimbel, Elizabeth ; Walawander, Ann ; Wood, Kenneth ; Taylor, Jeff ; Peel, Bruce ; Cook, Jon ; Brosgart, Carol ; Rooney, James ; Karol, Cheryl ; De Caprariis, Pascal ; Berg, Jeanne ; Heath-Chiozzi, Margo ; Sun, Eugene ; Becker, Mark ; Martinez, Ana ; Shepard, Robin ; Kerkau, Melissa ; Dragavon, Joan ; Jack, Michelle ; Yuan, Vivian ; Coombs, Robert ; Kenton, Antoinette ; Shriver, Sharon ; Jiang, Hongyu. / Durability of response to treatment among antiretroviral-experienced subjects : 48-Week results from AIDS Clinical Trials Group Protocol 359. In: Journal of Infectious Diseases. 2002 ; Vol. 186, No. 5. pp. 626-633.
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AU - Fischl, Margaret

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AU - Katzenstein, David

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AU - Talabucon, Candida T.

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AU - Kalajian, Robert

AU - Nelson, Margaret

AU - Ingersol, Kim

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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.

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AU - Carr, Stuart

AU - Shoemaker, Mary

AU - Hewitt, Ross

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AU - Lertora, Juan J.L.

AU - Beilke, Mark

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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

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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.

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