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Activity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose- Ranging Clinical Trial

Background. This phase 2, randomized, active-controlled, 48-week study assessed the noninferiority of the human immunodeficiency virus (HIV) integrase inhibitor elvitegravir to comparator ritonavir-boosted protease inhibitor (CPI/r) in treatment-experienced subjects. Methods. Subjects had HIV RNA le... Full description

Journal Title: Journal of Infectious Diseases 0, 2010, Vol.201(6), pp.814-822
Main Author: Zolopa, Andrew
Other Authors: Berger, Daniel , Lampiris, Harry , Zhong, Lijie , Chuck, Steven , Enejosa, Jeffrey , Kearney, Brian , Cheng, Andrew
Format: Electronic Article Electronic Article
Language: English
Subjects:
RNA
Quelle: © ProQuest LLC All rights reserved
ID: ISSN: 0022-1899 ; DOI: 10.1086/650698
Link: http://search.proquest.com/docview/745978331/
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title: Activity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose- Ranging Clinical Trial
format: Article
creator:
  • Zolopa, Andrew
  • Berger, Daniel
  • Lampiris, Harry
  • Zhong, Lijie
  • Chuck, Steven
  • Enejosa, Jeffrey
  • Kearney, Brian
  • Cheng, Andrew
subjects:
  • Data Processing
  • RNA
  • Ritonavir
  • Nucleosides
  • Proteinase Inhibitors
  • Antiviral Activity
  • Mutation
  • Clinical Trials
  • Thymidine
  • Nucleotides
  • Integrase
  • Human Immunodeficiency Virus
  • Human Immunodeficiency Virus 2
  • AIDS and HIV
  • Antibiotics & Antimicrobials
ispartof: Journal of Infectious Diseases, 0, 2010, Vol.201(6), pp.814-822
description: Background. This phase 2, randomized, active-controlled, 48-week study assessed the noninferiority of the human immunodeficiency virus (HIV) integrase inhibitor elvitegravir to comparator ritonavir-boosted protease inhibitor (CPI/r) in treatment-experienced subjects. Methods. Subjects had HIV RNA levels [image]1000 copies/mL and [image]1 protease resistance mutation. Subjects received nucleoside or nucleotide reverse-transcriptase inhibitors (NRTIs) with or without T-20 and either CPI/r or once-daily elvitegravir at a dose of 20 mg, 50 mg, or 125 mg (blinded to dose) with ritonavir. After week 8, the independent data monitoring committee stopped the elvitegravir 20 mg arm and allowed subjects in the elvitegravir 50 mg and 125 mg arms to add protease inhibitors. The primary end point was the time- weighted average change from baseline in HIV RNA level through week 24 (DAVG sub(24)). Results. A total of 278 subjects with a median of 11 protease and 3 thymidine analog mutations were randomized and treated. One-half of subjects received NRTIs without expected antiviral activity. Compared with the DAVG sub(24) for the CPI/r arm (-1.19 log sub(10) copies/mL), the elvitegravir 50 mg arm was noninferior (-1.44 log sub(10) copies/mL), and the elvitegravir 125 mg arm was superior (-1.66 log sub(10) copies/mL; [image]). Efficacy was impacted by activity of background agents. There was no relationship between elvitegravir dosage and adverse events. Conclusions. Elvitegravir was well-tolerated and produced rapid virologic suppression that was durable with active background therapy. Trial registration. ClinicalTrials.gov identifier number: NCT00298350.
language: eng
source: © ProQuest LLC All rights reserved
identifier: ISSN: 0022-1899 ; DOI: 10.1086/650698
fulltext: fulltext
issn:
  • 00221899
  • 0022-1899
url: Link


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titleActivity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose- Ranging Clinical Trial
creatorZolopa, Andrew ; Berger, Daniel ; Lampiris, Harry ; Zhong, Lijie ; Chuck, Steven ; Enejosa, Jeffrey ; Kearney, Brian ; Cheng, Andrew
contributorZolopa, Andrew (correspondence author)
ispartofJournal of Infectious Diseases, 0, 2010, Vol.201(6), pp.814-822
identifierISSN: 0022-1899 ; DOI: 10.1086/650698
subjectData Processing ; RNA ; Ritonavir ; Nucleosides ; Proteinase Inhibitors ; Antiviral Activity ; Mutation ; Clinical Trials ; Thymidine ; Nucleotides ; Integrase ; Human Immunodeficiency Virus ; Human Immunodeficiency Virus 2 ; AIDS and HIV ; Antibiotics & Antimicrobials
descriptionBackground. This phase 2, randomized, active-controlled, 48-week study assessed the noninferiority of the human immunodeficiency virus (HIV) integrase inhibitor elvitegravir to comparator ritonavir-boosted protease inhibitor (CPI/r) in treatment-experienced subjects. Methods. Subjects had HIV RNA levels [image]1000 copies/mL and [image]1 protease resistance mutation. Subjects received nucleoside or nucleotide reverse-transcriptase inhibitors (NRTIs) with or without T-20 and either CPI/r or once-daily elvitegravir at a dose of 20 mg, 50 mg, or 125 mg (blinded to dose) with ritonavir. After week 8, the independent data monitoring committee stopped the elvitegravir 20 mg arm and allowed subjects in the elvitegravir 50 mg and 125 mg arms to add protease inhibitors. The primary end point was the time- weighted average change from baseline in HIV RNA level through week 24 (DAVG sub(24)). Results. A total of 278 subjects with a median of 11 protease and 3 thymidine analog mutations were randomized and treated. One-half of subjects received NRTIs without expected antiviral activity. Compared with the DAVG sub(24) for the CPI/r arm (-1.19 log sub(10) copies/mL), the elvitegravir 50 mg arm was noninferior (-1.44 log sub(10) copies/mL), and the elvitegravir 125 mg arm was superior (-1.66 log sub(10) copies/mL; [image]). Efficacy was impacted by activity of background agents. There was no relationship between elvitegravir dosage and adverse events. Conclusions. Elvitegravir was well-tolerated and produced rapid virologic suppression that was durable with active background therapy. Trial registration. ClinicalTrials.gov identifier number: NCT00298350.
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titleActivity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose- Ranging Clinical Trial
descriptionBackground. This phase 2, randomized, active-controlled, 48-week study assessed the noninferiority of the human immunodeficiency virus (HIV) integrase inhibitor elvitegravir to comparator ritonavir-boosted protease inhibitor (CPI/r) in treatment-experienced subjects. Methods. Subjects had HIV RNA levels [image]1000 copies/mL and [image]1 protease resistance mutation. Subjects received nucleoside or nucleotide reverse-transcriptase inhibitors (NRTIs) with or without T-20 and either CPI/r or once-daily elvitegravir at a dose of 20 mg, 50 mg, or 125 mg (blinded to dose) with ritonavir. After week 8, the independent data monitoring committee stopped the elvitegravir 20 mg arm and allowed subjects in the elvitegravir 50 mg and 125 mg arms to add protease inhibitors. The primary end point was the time- weighted average change from baseline in HIV RNA level through week 24 (DAVG sub(24)). Results. A total of 278 subjects with a median of 11 protease and 3 thymidine analog mutations were randomized and treated. One-half of subjects received NRTIs without expected antiviral activity. Compared with the DAVG sub(24) for the CPI/r arm (-1.19 log sub(10) copies/mL), the elvitegravir 50 mg arm was noninferior (-1.44 log sub(10) copies/mL), and the elvitegravir 125 mg arm was superior (-1.66 log sub(10) copies/mL; [image]). Efficacy was impacted by activity of background agents. There was no relationship between elvitegravir dosage and adverse events. Conclusions. Elvitegravir was well-tolerated and produced rapid virologic suppression that was durable with active background therapy. Trial registration. ClinicalTrials.gov identifier number: NCT00298350.
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titleActivity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose- Ranging Clinical Trial
authorZolopa, Andrew ; Berger, Daniel ; Lampiris, Harry ; Zhong, Lijie ; Chuck, Steven ; Enejosa, Jeffrey ; Kearney, Brian ; Cheng, Andrew
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5Antiviral Activity
6Mutation
7Clinical Trials
8Thymidine
9Nucleotides
10Integrase
11Human Immunodeficiency Virus
12Human Immunodeficiency Virus 2
13AIDS and HIV
14Antibiotics & Antimicrobials
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abstractBackground. This phase 2, randomized, active-controlled, 48-week study assessed the noninferiority of the human immunodeficiency virus (HIV) integrase inhibitor elvitegravir to comparator ritonavir-boosted protease inhibitor (CPI/r) in treatment-experienced subjects. Methods. Subjects had HIV RNA levels [image]1000 copies/mL and [image]1 protease resistance mutation. Subjects received nucleoside or nucleotide reverse-transcriptase inhibitors (NRTIs) with or without T-20 and either CPI/r or once-daily elvitegravir at a dose of 20 mg, 50 mg, or 125 mg (blinded to dose) with ritonavir. After week 8, the independent data monitoring committee stopped the elvitegravir 20 mg arm and allowed subjects in the elvitegravir 50 mg and 125 mg arms to add protease inhibitors. The primary end point was the time- weighted average change from baseline in HIV RNA level through week 24 (DAVG sub(24)). Results. A total of 278 subjects with a median of 11 protease and 3 thymidine analog mutations were randomized and treated. One-half of subjects received NRTIs without expected antiviral activity. Compared with the DAVG sub(24) for the CPI/r arm (-1.19 log sub(10) copies/mL), the elvitegravir 50 mg arm was noninferior (-1.44 log sub(10) copies/mL), and the elvitegravir 125 mg arm was superior (-1.66 log sub(10) copies/mL; [image]). Efficacy was impacted by activity of background agents. There was no relationship between elvitegravir dosage and adverse events. Conclusions. Elvitegravir was well-tolerated and produced rapid virologic suppression that was durable with active background therapy. Trial registration. ClinicalTrials.gov identifier number: NCT00298350.
doi10.1086/650698
urlhttp://search.proquest.com/docview/745978331/
eissn15376613
date2010-01-01