Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS clinical trials group protocol 373

Roy M. Gulick, Laura M. Smeaton, Richard T. D’Aquila, Joseph J. Eron, Judith S. Currier, John G. Gerber, Edward Acosta, Jean Pierre Sommadossi, Roger Tung, Sally Snyder, Daniel R. Kuritzkes, Robert L. Murphy, Bruce Cohen, Joyce Drury, Baiba Berzins, Debra Johnson, Virgilio Clemente, Karen Cavanagh, Michelle Phillip, Ernesto G. ScerpellaAllan E Rodriguez, Michael K. Klebert, Pablo Tebas, M. Graham Ray, Sally Canmann, Melody Pratt-Palmore, Sherree Wright, Timothy Cooley, Carolyn Koziol, Ian Frank, Christopher Helker, Linh Ngo, Nazneen Howerton, Wende Levy, Antoinette Kenton, Diane Daria, John Ioannidis, Elizabeth Adams, Ana Martinez, Anne Kmack, Mary Jo Werder, Jules Levin, Robert Curry, Marita McDonough, Patrick Robinson, Michael Stevens, Michael Rogers, Daniel Stein, Randi Leavitt, Melissa Seniuk, John Alam, Pravin Chaturvedi, Judith Partaledis

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59%) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal ≥500 copies/mL) and CD4 cell counts increased by 94 cells/mm3 from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P = .0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable-virologic suppression.

Original languageEnglish (US)
Pages (from-to)715-721
Number of pages7
JournalJournal of Infectious Diseases
Volume183
Issue number5
DOIs
StatePublished - 2001

Fingerprint

Indinavir
Clinical Protocols
Acquired Immunodeficiency Syndrome
Clinical Trials
HIV
CD4 Lymphocyte Count
Pharmaceutical Preparations
RNA
Stavudine
Nevirapine
Lamivudine
Odds Ratio
amprenavir
stavudine, lamivudine, nevirapine drug combination
Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects : AIDS clinical trials group protocol 373. / Gulick, Roy M.; Smeaton, Laura M.; D’Aquila, Richard T.; Eron, Joseph J.; Currier, Judith S.; Gerber, John G.; Acosta, Edward; Sommadossi, Jean Pierre; Tung, Roger; Snyder, Sally; Kuritzkes, Daniel R.; Murphy, Robert L.; Cohen, Bruce; Drury, Joyce; Berzins, Baiba; Johnson, Debra; Clemente, Virgilio; Cavanagh, Karen; Phillip, Michelle; Scerpella, Ernesto G.; Rodriguez, Allan E; Klebert, Michael K.; Tebas, Pablo; Ray, M. Graham; Canmann, Sally; Pratt-Palmore, Melody; Wright, Sherree; Cooley, Timothy; Koziol, Carolyn; Frank, Ian; Helker, Christopher; Ngo, Linh; Howerton, Nazneen; Levy, Wende; Kenton, Antoinette; Daria, Diane; Ioannidis, John; Adams, Elizabeth; Martinez, Ana; Kmack, Anne; Werder, Mary Jo; Levin, Jules; Curry, Robert; McDonough, Marita; Robinson, Patrick; Stevens, Michael; Rogers, Michael; Stein, Daniel; Leavitt, Randi; Seniuk, Melissa; Alam, John; Chaturvedi, Pravin; Partaledis, Judith.

In: Journal of Infectious Diseases, Vol. 183, No. 5, 2001, p. 715-721.

Research output: Contribution to journalArticle

Gulick, RM, Smeaton, LM, D’Aquila, RT, Eron, JJ, Currier, JS, Gerber, JG, Acosta, E, Sommadossi, JP, Tung, R, Snyder, S, Kuritzkes, DR, Murphy, RL, Cohen, B, Drury, J, Berzins, B, Johnson, D, Clemente, V, Cavanagh, K, Phillip, M, Scerpella, EG, Rodriguez, AE, Klebert, MK, Tebas, P, Ray, MG, Canmann, S, Pratt-Palmore, M, Wright, S, Cooley, T, Koziol, C, Frank, I, Helker, C, Ngo, L, Howerton, N, Levy, W, Kenton, A, Daria, D, Ioannidis, J, Adams, E, Martinez, A, Kmack, A, Werder, MJ, Levin, J, Curry, R, McDonough, M, Robinson, P, Stevens, M, Rogers, M, Stein, D, Leavitt, R, Seniuk, M, Alam, J, Chaturvedi, P & Partaledis, J 2001, 'Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS clinical trials group protocol 373', Journal of Infectious Diseases, vol. 183, no. 5, pp. 715-721. https://doi.org/10.1086/318820
Gulick, Roy M. ; Smeaton, Laura M. ; D’Aquila, Richard T. ; Eron, Joseph J. ; Currier, Judith S. ; Gerber, John G. ; Acosta, Edward ; Sommadossi, Jean Pierre ; Tung, Roger ; Snyder, Sally ; Kuritzkes, Daniel R. ; Murphy, Robert L. ; Cohen, Bruce ; Drury, Joyce ; Berzins, Baiba ; Johnson, Debra ; Clemente, Virgilio ; Cavanagh, Karen ; Phillip, Michelle ; Scerpella, Ernesto G. ; Rodriguez, Allan E ; Klebert, Michael K. ; Tebas, Pablo ; Ray, M. Graham ; Canmann, Sally ; Pratt-Palmore, Melody ; Wright, Sherree ; Cooley, Timothy ; Koziol, Carolyn ; Frank, Ian ; Helker, Christopher ; Ngo, Linh ; Howerton, Nazneen ; Levy, Wende ; Kenton, Antoinette ; Daria, Diane ; Ioannidis, John ; Adams, Elizabeth ; Martinez, Ana ; Kmack, Anne ; Werder, Mary Jo ; Levin, Jules ; Curry, Robert ; McDonough, Marita ; Robinson, Patrick ; Stevens, Michael ; Rogers, Michael ; Stein, Daniel ; Leavitt, Randi ; Seniuk, Melissa ; Alam, John ; Chaturvedi, Pravin ; Partaledis, Judith. / Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects : AIDS clinical trials group protocol 373. In: Journal of Infectious Diseases. 2001 ; Vol. 183, No. 5. pp. 715-721.
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abstract = "This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59{\%}) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal ≥500 copies/mL) and CD4 cell counts increased by 94 cells/mm3 from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P = .0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable-virologic suppression.",
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AU - Smeaton, Laura M.

AU - D’Aquila, Richard T.

AU - Eron, Joseph J.

AU - Currier, Judith S.

AU - Gerber, John G.

AU - Acosta, Edward

AU - Sommadossi, Jean Pierre

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AU - Snyder, Sally

AU - Kuritzkes, Daniel R.

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AU - Cohen, Bruce

AU - Drury, Joyce

AU - Berzins, Baiba

AU - Johnson, Debra

AU - Clemente, Virgilio

AU - Cavanagh, Karen

AU - Phillip, Michelle

AU - Scerpella, Ernesto G.

AU - Rodriguez, Allan E

AU - Klebert, Michael K.

AU - Tebas, Pablo

AU - Ray, M. Graham

AU - Canmann, Sally

AU - Pratt-Palmore, Melody

AU - Wright, Sherree

AU - Cooley, Timothy

AU - Koziol, Carolyn

AU - Frank, Ian

AU - Helker, Christopher

AU - Ngo, Linh

AU - Howerton, Nazneen

AU - Levy, Wende

AU - Kenton, Antoinette

AU - Daria, Diane

AU - Ioannidis, John

AU - Adams, Elizabeth

AU - Martinez, Ana

AU - Kmack, Anne

AU - Werder, Mary Jo

AU - Levin, Jules

AU - Curry, Robert

AU - McDonough, Marita

AU - Robinson, Patrick

AU - Stevens, Michael

AU - Rogers, Michael

AU - Stein, Daniel

AU - Leavitt, Randi

AU - Seniuk, Melissa

AU - Alam, John

AU - Chaturvedi, Pravin

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