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Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial

Summary Background Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the efficacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods DUET-1 is a... Full description

Journal Title: The Lancet (British edition) 2007, Vol.370 (9581), p.29-38
Main Author: Madruga, José Valdez, Dr
Other Authors: Cahn, Pedro, MD , Grinsztejn, Beatriz, MD , Haubrich, Richard, Prof , Lalezari, Jacob, MD , Mills, Anthony, MD , Pialoux, Gilles, Prof , Wilkin, Timothy, MD , Peeters, Monika, MSc , Vingerhoets, Johan, PhD , de Smedt, Goedele, MD , Leopold, Lorant, MD , Trefiglio, Roberta, PharmD , Woodfall, Brian, MD
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/17617270
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title: Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
format: Article
creator:
  • Madruga, José Valdez, Dr
  • Cahn, Pedro, MD
  • Grinsztejn, Beatriz, MD
  • Haubrich, Richard, Prof
  • Lalezari, Jacob, MD
  • Mills, Anthony, MD
  • Pialoux, Gilles, Prof
  • Wilkin, Timothy, MD
  • Peeters, Monika, MSc
  • Vingerhoets, Johan, PhD
  • de Smedt, Goedele, MD
  • Leopold, Lorant, MD
  • Trefiglio, Roberta, PharmD
  • Woodfall, Brian, MD
subjects:
  • Adult
  • Aged
  • Anti-HIV Agents - adverse effects
  • Anti-HIV Agents - therapeutic use
  • Antiretroviral drugs
  • Clinical trials
  • Double-Blind Method
  • Drug resistance
  • Female
  • Genotype & phenotype
  • HIV
  • HIV Infections - classification
  • HIV Infections - drug therapy
  • HIV-1 - drug effects
  • Human immunodeficiency virus
  • Humans
  • Internal Medicine
  • Male
  • Middle Aged
  • Mutation
  • Patients
  • Physical examinations
  • Pyridazines - adverse effects
  • Pyridazines - therapeutic use
  • Severity of Illness Index
ispartof: The Lancet (British edition), 2007, Vol.370 (9581), p.29-38
description: Summary Background Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the efficacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confirmed viral load below 50 copies per mL at week 24 (FDA time-to-loss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , with the number NCT00254046. Findings 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profile of TMC125 was generally comparable with placebo.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleEfficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
sourceAlma/SFX Local Collection
creatorMadruga, José Valdez, Dr ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Haubrich, Richard, Prof ; Lalezari, Jacob, MD ; Mills, Anthony, MD ; Pialoux, Gilles, Prof ; Wilkin, Timothy, MD ; Peeters, Monika, MSc ; Vingerhoets, Johan, PhD ; de Smedt, Goedele, MD ; Leopold, Lorant, MD ; Trefiglio, Roberta, PharmD ; Woodfall, Brian, MD
creatorcontribMadruga, José Valdez, Dr ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Haubrich, Richard, Prof ; Lalezari, Jacob, MD ; Mills, Anthony, MD ; Pialoux, Gilles, Prof ; Wilkin, Timothy, MD ; Peeters, Monika, MSc ; Vingerhoets, Johan, PhD ; de Smedt, Goedele, MD ; Leopold, Lorant, MD ; Trefiglio, Roberta, PharmD ; Woodfall, Brian, MD ; on behalf of the DUET-1 study group ; DUET-1 study group
descriptionSummary Background Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the efficacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confirmed viral load below 50 copies per mL at week 24 (FDA time-to-loss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , with the number NCT00254046. Findings 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profile of TMC125 was generally comparable with placebo.
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subjectAdult ; Aged ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; Clinical trials ; Double-Blind Method ; Drug resistance ; Female ; Genotype & phenotype ; HIV ; HIV Infections - classification ; HIV Infections - drug therapy ; HIV-1 - drug effects ; Human immunodeficiency virus ; Humans ; Internal Medicine ; Male ; Middle Aged ; Mutation ; Patients ; Physical examinations ; Pyridazines - adverse effects ; Pyridazines - therapeutic use ; Severity of Illness Index
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2Grinsztejn, Beatriz, MD
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6Pialoux, Gilles, Prof
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8Peeters, Monika, MSc
9Vingerhoets, Johan, PhD
10de Smedt, Goedele, MD
11Leopold, Lorant, MD
12Trefiglio, Roberta, PharmD
13Woodfall, Brian, MD
14on behalf of the DUET-1 study group
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0Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
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descriptionSummary Background Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the efficacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confirmed viral load below 50 copies per mL at week 24 (FDA time-to-loss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , with the number NCT00254046. Findings 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profile of TMC125 was generally comparable with placebo.
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titleEfficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
authorMadruga, José Valdez, Dr ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Haubrich, Richard, Prof ; Lalezari, Jacob, MD ; Mills, Anthony, MD ; Pialoux, Gilles, Prof ; Wilkin, Timothy, MD ; Peeters, Monika, MSc ; Vingerhoets, Johan, PhD ; de Smedt, Goedele, MD ; Leopold, Lorant, MD ; Trefiglio, Roberta, PharmD ; Woodfall, Brian, MD
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9Genotype & phenotype
10HIV
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abstractSummary Background Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the efficacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confirmed viral load below 50 copies per mL at week 24 (FDA time-to-loss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , with the number NCT00254046. Findings 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profile of TMC125 was generally comparable with placebo.
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pubElsevier Ltd
pmid17617270
doi10.1016/S0140-6736(07)61047-2