Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients: Results of adult AIDS clinical trials group protocol 370

Daniel R. Kuritzkes, Roland L. Bassett, Victoria A. Johnson, Ian C. Marschner, Joseph J. Eron, Jean Pierre Sommadossi, Edward P. Acosta, Robert L. Murphy, Kenneth Fife, Kenneth Wood, Dawn Bell, Ana Martinez, Carla B. Pettinelli

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Objective: To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients. Design: Randomized, open-label, multi-center study. Setting: Adult AIDS clinical trials units. Patients: Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks. Interventions: Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddl + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. Main outcome measures: Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at week 48 was a secondary endpoint. Result: At week 24, 58% of subjects in the ZDV + 3TC + IDV arm and 73% in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels ≤ 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were ≤ 200 copies/ml in 48% and 83%, respectively (P= 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm. Conclusions: Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics. (C) 2000 Lippincott Williams and Wilkins.

Original languageEnglish
Pages (from-to)1553-1561
Number of pages9
JournalAIDS
Volume14
Issue number11
DOIs
StatePublished - 2000

Fingerprint

Delavirdine
Indinavir
Stavudine
Lamivudine
Zidovudine
Clinical Protocols
Acquired Immunodeficiency Syndrome
Clinical Trials
HIV-1
RNA
Nucleosides
Didanosine
Reverse Transcriptase Inhibitors
Hyperbilirubinemia
Exanthema
Protease Inhibitors

Keywords

  • HIV-1
  • Non-nucleoside reverse transcriptase inhibitor
  • Nucleoside analog
  • Protease inhibitor
  • Reverse transcriptase inhibitor

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients : Results of adult AIDS clinical trials group protocol 370. / Kuritzkes, Daniel R.; Bassett, Roland L.; Johnson, Victoria A.; Marschner, Ian C.; Eron, Joseph J.; Sommadossi, Jean Pierre; Acosta, Edward P.; Murphy, Robert L.; Fife, Kenneth; Wood, Kenneth; Bell, Dawn; Martinez, Ana; Pettinelli, Carla B.

In: AIDS, Vol. 14, No. 11, 2000, p. 1553-1561.

Research output: Contribution to journalArticle

Kuritzkes, DR, Bassett, RL, Johnson, VA, Marschner, IC, Eron, JJ, Sommadossi, JP, Acosta, EP, Murphy, RL, Fife, K, Wood, K, Bell, D, Martinez, A & Pettinelli, CB 2000, 'Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients: Results of adult AIDS clinical trials group protocol 370', AIDS, vol. 14, no. 11, pp. 1553-1561. https://doi.org/10.1097/00002030-200007280-00011
Kuritzkes, Daniel R. ; Bassett, Roland L. ; Johnson, Victoria A. ; Marschner, Ian C. ; Eron, Joseph J. ; Sommadossi, Jean Pierre ; Acosta, Edward P. ; Murphy, Robert L. ; Fife, Kenneth ; Wood, Kenneth ; Bell, Dawn ; Martinez, Ana ; Pettinelli, Carla B. / Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients : Results of adult AIDS clinical trials group protocol 370. In: AIDS. 2000 ; Vol. 14, No. 11. pp. 1553-1561.
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abstract = "Objective: To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients. Design: Randomized, open-label, multi-center study. Setting: Adult AIDS clinical trials units. Patients: Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks. Interventions: Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddl + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. Main outcome measures: Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at week 48 was a secondary endpoint. Result: At week 24, 58{\%} of subjects in the ZDV + 3TC + IDV arm and 73{\%} in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels ≤ 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were ≤ 200 copies/ml in 48{\%} and 83{\%}, respectively (P= 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm. Conclusions: Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics. (C) 2000 Lippincott Williams and Wilkins.",
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TY - JOUR

T1 - Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients

T2 - Results of adult AIDS clinical trials group protocol 370

AU - Kuritzkes, Daniel R.

AU - Bassett, Roland L.

AU - Johnson, Victoria A.

AU - Marschner, Ian C.

AU - Eron, Joseph J.

AU - Sommadossi, Jean Pierre

AU - Acosta, Edward P.

AU - Murphy, Robert L.

AU - Fife, Kenneth

AU - Wood, Kenneth

AU - Bell, Dawn

AU - Martinez, Ana

AU - Pettinelli, Carla B.

PY - 2000

Y1 - 2000

N2 - Objective: To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients. Design: Randomized, open-label, multi-center study. Setting: Adult AIDS clinical trials units. Patients: Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks. Interventions: Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddl + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. Main outcome measures: Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at week 48 was a secondary endpoint. Result: At week 24, 58% of subjects in the ZDV + 3TC + IDV arm and 73% in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels ≤ 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were ≤ 200 copies/ml in 48% and 83%, respectively (P= 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm. Conclusions: Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics. (C) 2000 Lippincott Williams and Wilkins.

AB - Objective: To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients. Design: Randomized, open-label, multi-center study. Setting: Adult AIDS clinical trials units. Patients: Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks. Interventions: Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddl + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. Main outcome measures: Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels ≤ 200 copies/ml at week 48 was a secondary endpoint. Result: At week 24, 58% of subjects in the ZDV + 3TC + IDV arm and 73% in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels ≤ 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were ≤ 200 copies/ml in 48% and 83%, respectively (P= 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm. Conclusions: Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics. (C) 2000 Lippincott Williams and Wilkins.

KW - HIV-1

KW - Non-nucleoside reverse transcriptase inhibitor

KW - Nucleoside analog

KW - Protease inhibitor

KW - Reverse transcriptase inhibitor

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