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Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study

Summary Background Uncertainty exists about the best treatment for people with HIV-1 who have virological failure with first-line combination antiretroviral therapy of a non-nucleoside analogue (NNRTI) plus two nucleoside or nucleotide analogue reverse transcriptase inhibitors (NtRTI). We compared a... Full description

Journal Title: The Lancet (British edition) 2013, Vol.381 (9883), p.2091-2099
Main Author: Boyd, M A
Other Authors: Kumarasamy, N , Moore, C L , Nwizu, C , Losso, M H , Mohapi, L , Martin, A , Kerr, S , Sohn, A H , Teppler, H , Van de Steen, O , Molina, J-M , Emery, S , Cooper, D A
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study
format: Article
creator:
  • Boyd, M A
  • Kumarasamy, N
  • Moore, C L
  • Nwizu, C
  • Losso, M H
  • Mohapi, L
  • Martin, A
  • Kerr, S
  • Sohn, A H
  • Teppler, H
  • Van de Steen, O
  • Molina, J-M
  • Emery, S
  • Cooper, D A
subjects:
  • Abridged Index Medicus
  • Adult
  • Anti-HIV Agents - administration & dosage
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • Antiretroviral drugs
  • Antiviral agents
  • Biological and medical sciences
  • Cholesterol
  • Complications and side effects
  • Consent
  • Dosage and administration
  • Drug resistance
  • Drug therapy
  • Drug Therapy, Combination
  • Female
  • General aspects
  • Hepatitis
  • HIV
  • HIV infection
  • HIV Infections - drug therapy
  • HIV Infections - virology
  • HIV Protease Inhibitors - administration & dosage
  • HIV-1 - drug effects
  • Homeostasis
  • Human immunodeficiency virus
  • Human immunodeficiency virus 1
  • Human viral diseases
  • Humans
  • Infectious diseases
  • Internal Medicine
  • Lopinavir - administration & dosage
  • Low income groups
  • Male
  • Medical sciences
  • Nucleosides - administration & dosage
  • Nucleotides - administration & dosage
  • Pharmacology. Drug treatments
  • Plasma
  • Pyrrolidinones - administration & dosage
  • Raltegravir Potassium
  • Reverse transcriptase inhibitors
  • Reverse Transcriptase Inhibitors - administration & dosage
  • Ritonavir - administration & dosage
  • Studies
  • Treatment Outcome
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
  • Viral infections
ispartof: The Lancet (British edition), 2013, Vol.381 (9883), p.2091-2099
description: Summary Background Uncertainty exists about the best treatment for people with HIV-1 who have virological failure with first-line combination antiretroviral therapy of a non-nucleoside analogue (NNRTI) plus two nucleoside or nucleotide analogue reverse transcriptase inhibitors (NtRTI). We compared a second-line regimen combining two new classes of drug with a WHO-recommended regimen. Methods We did this 96-week, phase 3b/4, randomised, open-label non-inferiority trial at 37 sites worldwide. Adults with HIV-1 who had confirmed virological failure (plasma viral load >500 copies per mL) after 24 weeks or more of first-line treatment were randomly assigned (1:1) to receive ritonavir-boosted lopinavir plus two or three NtRTIs (control group) or ritonavir-boosted lopinavir plus raltegravir (raltegravir group). The randomisation sequence was computer generated with block randomisation (block size four). Neither participants nor investigators were masked to allocation. The primary endpoint was the proportion of participants with plasma viral load less than 200 copies per mL at 48 weeks in the modified intention-to-treat population, with a non-inferiority margin of 12%. This study is registered with ClinicalTrials.gov , number NCT00931463. Findings We enrolled 558 patients, of whom 541 (271 in the control group, 270 in the raltegravir group) were included in the primary analysis. At 48 weeks, 219 (81%) patients in the control group compared with 223 (83%) in the raltegravir group met the primary endpoint (difference 1·8%, 95% CI −4·7 to 8·3), fulfilling the criterion for non-inferiority. 993 adverse events occurred in 271 participants in the control group versus 895 in 270 participants in the raltegravir group, the most common being gastrointestinal. Interpretation The raltegravir regimen was no less efficacious than the standard of care and was safe and well tolerated. This simple NtRTI-free treatment strategy might extend the successful public health approach to management of HIV by providing simple, easy to administer, effective, safe, and tolerable second-line combination antiretroviral therapy. Funding University of New South Wales, Merck, AbbVie, the Foundation for AIDS Research.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleRitonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study
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creatorBoyd, M A ; Kumarasamy, N ; Moore, C L ; Nwizu, C ; Losso, M H ; Mohapi, L ; Martin, A ; Kerr, S ; Sohn, A H ; Teppler, H ; Van de Steen, O ; Molina, J-M ; Emery, S ; Cooper, D A
creatorcontribBoyd, M A ; Kumarasamy, N ; Moore, C L ; Nwizu, C ; Losso, M H ; Mohapi, L ; Martin, A ; Kerr, S ; Sohn, A H ; Teppler, H ; Van de Steen, O ; Molina, J-M ; Emery, S ; Cooper, D A ; SECOND-LINE Study Group
descriptionSummary Background Uncertainty exists about the best treatment for people with HIV-1 who have virological failure with first-line combination antiretroviral therapy of a non-nucleoside analogue (NNRTI) plus two nucleoside or nucleotide analogue reverse transcriptase inhibitors (NtRTI). We compared a second-line regimen combining two new classes of drug with a WHO-recommended regimen. Methods We did this 96-week, phase 3b/4, randomised, open-label non-inferiority trial at 37 sites worldwide. Adults with HIV-1 who had confirmed virological failure (plasma viral load >500 copies per mL) after 24 weeks or more of first-line treatment were randomly assigned (1:1) to receive ritonavir-boosted lopinavir plus two or three NtRTIs (control group) or ritonavir-boosted lopinavir plus raltegravir (raltegravir group). The randomisation sequence was computer generated with block randomisation (block size four). Neither participants nor investigators were masked to allocation. The primary endpoint was the proportion of participants with plasma viral load less than 200 copies per mL at 48 weeks in the modified intention-to-treat population, with a non-inferiority margin of 12%. This study is registered with ClinicalTrials.gov , number NCT00931463. Findings We enrolled 558 patients, of whom 541 (271 in the control group, 270 in the raltegravir group) were included in the primary analysis. At 48 weeks, 219 (81%) patients in the control group compared with 223 (83%) in the raltegravir group met the primary endpoint (difference 1·8%, 95% CI −4·7 to 8·3), fulfilling the criterion for non-inferiority. 993 adverse events occurred in 271 participants in the control group versus 895 in 270 participants in the raltegravir group, the most common being gastrointestinal. Interpretation The raltegravir regimen was no less efficacious than the standard of care and was safe and well tolerated. This simple NtRTI-free treatment strategy might extend the successful public health approach to management of HIV by providing simple, easy to administer, effective, safe, and tolerable second-line combination antiretroviral therapy. Funding University of New South Wales, Merck, AbbVie, the Foundation for AIDS Research.
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1Kumarasamy, N
2Moore, C L
3Nwizu, C
4Losso, M H
5Mohapi, L
6Martin, A
7Kerr, S
8Sohn, A H
9Teppler, H
10Van de Steen, O
11Molina, J-M
12Emery, S
13Cooper, D A
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title
0Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study
1The Lancet (British edition)
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descriptionSummary Background Uncertainty exists about the best treatment for people with HIV-1 who have virological failure with first-line combination antiretroviral therapy of a non-nucleoside analogue (NNRTI) plus two nucleoside or nucleotide analogue reverse transcriptase inhibitors (NtRTI). We compared a second-line regimen combining two new classes of drug with a WHO-recommended regimen. Methods We did this 96-week, phase 3b/4, randomised, open-label non-inferiority trial at 37 sites worldwide. Adults with HIV-1 who had confirmed virological failure (plasma viral load >500 copies per mL) after 24 weeks or more of first-line treatment were randomly assigned (1:1) to receive ritonavir-boosted lopinavir plus two or three NtRTIs (control group) or ritonavir-boosted lopinavir plus raltegravir (raltegravir group). The randomisation sequence was computer generated with block randomisation (block size four). Neither participants nor investigators were masked to allocation. The primary endpoint was the proportion of participants with plasma viral load less than 200 copies per mL at 48 weeks in the modified intention-to-treat population, with a non-inferiority margin of 12%. This study is registered with ClinicalTrials.gov , number NCT00931463. Findings We enrolled 558 patients, of whom 541 (271 in the control group, 270 in the raltegravir group) were included in the primary analysis. At 48 weeks, 219 (81%) patients in the control group compared with 223 (83%) in the raltegravir group met the primary endpoint (difference 1·8%, 95% CI −4·7 to 8·3), fulfilling the criterion for non-inferiority. 993 adverse events occurred in 271 participants in the control group versus 895 in 270 participants in the raltegravir group, the most common being gastrointestinal. Interpretation The raltegravir regimen was no less efficacious than the standard of care and was safe and well tolerated. This simple NtRTI-free treatment strategy might extend the successful public health approach to management of HIV by providing simple, easy to administer, effective, safe, and tolerable second-line combination antiretroviral therapy. Funding University of New South Wales, Merck, AbbVie, the Foundation for AIDS Research.
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4Antiretroviral drugs
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6Biological and medical sciences
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8Complications and side effects
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12Drug therapy
13Drug Therapy, Combination
14Female
15General aspects
16Hepatitis
17HIV
18HIV infection
19HIV Infections - drug therapy
20HIV Infections - virology
21HIV Protease Inhibitors - administration & dosage
22HIV-1 - drug effects
23Homeostasis
24Human immunodeficiency virus
25Human immunodeficiency virus 1
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27Humans
28Infectious diseases
29Internal Medicine
30Lopinavir - administration & dosage
31Low income groups
32Male
33Medical sciences
34Nucleosides - administration & dosage
35Nucleotides - administration & dosage
36Pharmacology. Drug treatments
37Plasma
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39Raltegravir Potassium
40Reverse transcriptase inhibitors
41Reverse Transcriptase Inhibitors - administration & dosage
42Ritonavir - administration & dosage
43Studies
44Treatment Outcome
45Viral diseases
46Viral diseases of the lymphoid tissue and the blood. Aids
47Viral infections
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titleRitonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study
authorBoyd, M A ; Kumarasamy, N ; Moore, C L ; Nwizu, C ; Losso, M H ; Mohapi, L ; Martin, A ; Kerr, S ; Sohn, A H ; Teppler, H ; Van de Steen, O ; Molina, J-M ; Emery, S ; Cooper, D A
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46Viral diseases of the lymphoid tissue and the blood. Aids
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1Kumarasamy, N
2Moore, C L
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4Losso, M H
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atitleRitonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study
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issue9883
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pages2091-2099
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abstractSummary Background Uncertainty exists about the best treatment for people with HIV-1 who have virological failure with first-line combination antiretroviral therapy of a non-nucleoside analogue (NNRTI) plus two nucleoside or nucleotide analogue reverse transcriptase inhibitors (NtRTI). We compared a second-line regimen combining two new classes of drug with a WHO-recommended regimen. Methods We did this 96-week, phase 3b/4, randomised, open-label non-inferiority trial at 37 sites worldwide. Adults with HIV-1 who had confirmed virological failure (plasma viral load >500 copies per mL) after 24 weeks or more of first-line treatment were randomly assigned (1:1) to receive ritonavir-boosted lopinavir plus two or three NtRTIs (control group) or ritonavir-boosted lopinavir plus raltegravir (raltegravir group). The randomisation sequence was computer generated with block randomisation (block size four). Neither participants nor investigators were masked to allocation. The primary endpoint was the proportion of participants with plasma viral load less than 200 copies per mL at 48 weeks in the modified intention-to-treat population, with a non-inferiority margin of 12%. This study is registered with ClinicalTrials.gov , number NCT00931463. Findings We enrolled 558 patients, of whom 541 (271 in the control group, 270 in the raltegravir group) were included in the primary analysis. At 48 weeks, 219 (81%) patients in the control group compared with 223 (83%) in the raltegravir group met the primary endpoint (difference 1·8%, 95% CI −4·7 to 8·3), fulfilling the criterion for non-inferiority. 993 adverse events occurred in 271 participants in the control group versus 895 in 270 participants in the raltegravir group, the most common being gastrointestinal. Interpretation The raltegravir regimen was no less efficacious than the standard of care and was safe and well tolerated. This simple NtRTI-free treatment strategy might extend the successful public health approach to management of HIV by providing simple, easy to administer, effective, safe, and tolerable second-line combination antiretroviral therapy. Funding University of New South Wales, Merck, AbbVie, the Foundation for AIDS Research.
copKidlington
pubElsevier Ltd
pmid23769235
doi10.1016/S0140-6736(13)61164-2