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Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial

Summary Background Daily oral triple therapy is effective at halting HIV disease progression, but can have toxic effects and is costly. We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy. Methods The GARDEL study (Global AntiR... Full description

Journal Title: The Lancet infectious diseases 2014, Vol.14 (7), p.572-580
Main Author: Cahn, Pedro, Dr
Other Authors: Andrade-Villanueva, Jaime, MD , Arribas, José R, MD , Gatell, José M, MD , Lama, Javier R, MD , Norton, Michael, MD , Patterson, Patricia, MD , Madero, Juan Sierra, MD , Sued, Omar, MD , Figueroa, Maria Inés, MD , Rolon, Maria José, MD
Format: Electronic Article Electronic Article
Language: English
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HIV
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Publisher: London: Elsevier Ltd
ID: ISSN: 1473-3099
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title: Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial
format: Article
creator:
  • Cahn, Pedro, Dr
  • Andrade-Villanueva, Jaime, MD
  • Arribas, José R, MD
  • Gatell, José M, MD
  • Lama, Javier R, MD
  • Norton, Michael, MD
  • Patterson, Patricia, MD
  • Madero, Juan Sierra, MD
  • Sued, Omar, MD
  • Figueroa, Maria Inés, MD
  • Rolon, Maria José, MD
subjects:
  • Adolescent
  • Adult
  • Aged
  • Anti-HIV Agents - therapeutic use
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • Antiretroviral drugs
  • Antiretroviral Therapy, Highly Active - methods
  • Antiviral agents
  • Biological and medical sciences
  • Clinical trials
  • DNA polymerases
  • Drug therapy
  • Female
  • Health aspects
  • HIV
  • HIV Infections - drug therapy
  • HIV Protease Inhibitors - therapeutic use
  • HIV-1
  • Human immunodeficiency virus
  • Human immunodeficiency virus 1
  • Human viral diseases
  • Humans
  • Immunodeficiencies
  • Immunodeficiencies. Immunoglobulinopathies
  • Immunopathology
  • Infectious Disease
  • Infectious diseases
  • Lamivudine
  • Lamivudine - therapeutic use
  • Lopinavir - therapeutic use
  • Male
  • Medical sciences
  • Middle Aged
  • Mutation
  • Nucleosides
  • Patients
  • Pharmacology. Drug treatments
  • Reverse Transcriptase Inhibitors - therapeutic use
  • Ritonavir - therapeutic use
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
  • Young Adult
ispartof: The Lancet infectious diseases, 2014, Vol.14 (7), p.572-580
description: Summary Background Daily oral triple therapy is effective at halting HIV disease progression, but can have toxic effects and is costly. We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy. Methods The GARDEL study (Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy) is a 48 week, phase 3, randomised, controlled, open-label, non-inferiority trial in antiretroviral-therapy-naive adults (age ≥18 years) with documented HIV-1 RNA viral load of at least 1000 copies per mL. The study was done at 19 centres in six countries. Patients were randomly assigned (1:1) to dual therapy or triple therapy by sealed envelopes, in blocks of four, stratified by baseline viral load (
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1473-3099
fulltext: fulltext
issn:
  • 1473-3099
  • 1474-4457
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titleDual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial
sourceAlma/SFX Local Collection
creatorCahn, Pedro, Dr ; Andrade-Villanueva, Jaime, MD ; Arribas, José R, MD ; Gatell, José M, MD ; Lama, Javier R, MD ; Norton, Michael, MD ; Patterson, Patricia, MD ; Madero, Juan Sierra, MD ; Sued, Omar, MD ; Figueroa, Maria Inés, MD ; Rolon, Maria José, MD
creatorcontribCahn, Pedro, Dr ; Andrade-Villanueva, Jaime, MD ; Arribas, José R, MD ; Gatell, José M, MD ; Lama, Javier R, MD ; Norton, Michael, MD ; Patterson, Patricia, MD ; Madero, Juan Sierra, MD ; Sued, Omar, MD ; Figueroa, Maria Inés, MD ; Rolon, Maria José, MD ; on behalf of the GARDEL Study Group ; GARDEL Study Group
descriptionSummary Background Daily oral triple therapy is effective at halting HIV disease progression, but can have toxic effects and is costly. We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy. Methods The GARDEL study (Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy) is a 48 week, phase 3, randomised, controlled, open-label, non-inferiority trial in antiretroviral-therapy-naive adults (age ≥18 years) with documented HIV-1 RNA viral load of at least 1000 copies per mL. The study was done at 19 centres in six countries. Patients were randomly assigned (1:1) to dual therapy or triple therapy by sealed envelopes, in blocks of four, stratified by baseline viral load (<100 000 vs ≥100 000 copies per mL). Dual therapy consisted of lopinavir 400 mg and ritonavir 100 mg plus lamivudine 150 mg, both twice daily. Triple therapy consisted of lopinavir 400 mg and ritonavir 100 mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor (NRTI) in fixed-dose combination. Efficacy was analysed in all participants who received at least one dose of study drug. The primary endpoint was virological response rate, defined as the proportion of patients with HIV RNA less than 50 copies per mL at 48 weeks. Dual therapy was classed as non-inferior to triple therapy if the lower bound of the 95% CI for the difference between groups was no lower than −12%. Patients and investigators were unmasked to treatment allocation. This study is registered with ClinicalTrials.gov , number NCT01237444. Findings Between Dec 10, 2010, and May 15, 2012, 217 patients were randomly assigned to the dual-therapy group and 209 to the triple-therapy group. 198 patients in the dual-therapy group and 175 in the triple-therapy group completed 48 weeks of treatment. At week 48, 189 patients (88·3%) in the dual-therapy group and 169 (83·7%) in the triple-therapy group had viral response (difference 4·6%, 95% CI −2·2 to 11·8; p=0·171). Patients with baseline viral load of at least 100 000 copies per mL showed similar results (87·2% vs 77·9%, respectively; difference 9·3%, 95% CI −2·8 to 21·5; p=0·145). Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group (n=10 [4·9%]) than in the dual-therapy group (n=1 [0·4%]; difference 4·5%, 95% CI −8·1 to −0·9; p=0·011). 65 adverse events in the dual-therapy group and 88 in the triple-therapy group were possibly or probably drug related (p=0·007). Two serious adverse events occurred, both in the dual-therapy arm, one of which (a case of gastritis) was reported as possibly or probably related to drug treatment. Interpretation Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients. Funding Fundación Huésped and AbbVie.
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languageeng
publisherLondon: Elsevier Ltd
subjectAdolescent ; Adult ; Aged ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral drugs ; Antiretroviral Therapy, Highly Active - methods ; Antiviral agents ; Biological and medical sciences ; Clinical trials ; DNA polymerases ; Drug therapy ; Female ; Health aspects ; HIV ; HIV Infections - drug therapy ; HIV Protease Inhibitors - therapeutic use ; HIV-1 ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious Disease ; Infectious diseases ; Lamivudine ; Lamivudine - therapeutic use ; Lopinavir - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Mutation ; Nucleosides ; Patients ; Pharmacology. Drug treatments ; Reverse Transcriptase Inhibitors - therapeutic use ; Ritonavir - therapeutic use ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Young Adult
ispartofThe Lancet infectious diseases, 2014, Vol.14 (7), p.572-580
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1Andrade-Villanueva, Jaime, MD
2Arribas, José R, MD
3Gatell, José M, MD
4Lama, Javier R, MD
5Norton, Michael, MD
6Patterson, Patricia, MD
7Madero, Juan Sierra, MD
8Sued, Omar, MD
9Figueroa, Maria Inés, MD
10Rolon, Maria José, MD
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12GARDEL Study Group
title
0Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial
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descriptionSummary Background Daily oral triple therapy is effective at halting HIV disease progression, but can have toxic effects and is costly. We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy. Methods The GARDEL study (Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy) is a 48 week, phase 3, randomised, controlled, open-label, non-inferiority trial in antiretroviral-therapy-naive adults (age ≥18 years) with documented HIV-1 RNA viral load of at least 1000 copies per mL. The study was done at 19 centres in six countries. Patients were randomly assigned (1:1) to dual therapy or triple therapy by sealed envelopes, in blocks of four, stratified by baseline viral load (<100 000 vs ≥100 000 copies per mL). Dual therapy consisted of lopinavir 400 mg and ritonavir 100 mg plus lamivudine 150 mg, both twice daily. Triple therapy consisted of lopinavir 400 mg and ritonavir 100 mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor (NRTI) in fixed-dose combination. Efficacy was analysed in all participants who received at least one dose of study drug. The primary endpoint was virological response rate, defined as the proportion of patients with HIV RNA less than 50 copies per mL at 48 weeks. Dual therapy was classed as non-inferior to triple therapy if the lower bound of the 95% CI for the difference between groups was no lower than −12%. Patients and investigators were unmasked to treatment allocation. This study is registered with ClinicalTrials.gov , number NCT01237444. Findings Between Dec 10, 2010, and May 15, 2012, 217 patients were randomly assigned to the dual-therapy group and 209 to the triple-therapy group. 198 patients in the dual-therapy group and 175 in the triple-therapy group completed 48 weeks of treatment. At week 48, 189 patients (88·3%) in the dual-therapy group and 169 (83·7%) in the triple-therapy group had viral response (difference 4·6%, 95% CI −2·2 to 11·8; p=0·171). Patients with baseline viral load of at least 100 000 copies per mL showed similar results (87·2% vs 77·9%, respectively; difference 9·3%, 95% CI −2·8 to 21·5; p=0·145). Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group (n=10 [4·9%]) than in the dual-therapy group (n=1 [0·4%]; difference 4·5%, 95% CI −8·1 to −0·9; p=0·011). 65 adverse events in the dual-therapy group and 88 in the triple-therapy group were possibly or probably drug related (p=0·007). Two serious adverse events occurred, both in the dual-therapy arm, one of which (a case of gastritis) was reported as possibly or probably related to drug treatment. Interpretation Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients. Funding Fundación Huésped and AbbVie.
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3Anti-HIV Agents - therapeutic use
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6Antiretroviral Therapy, Highly Active - methods
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10DNA polymerases
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12Female
13Health aspects
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15HIV Infections - drug therapy
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18Human immunodeficiency virus
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26Infectious diseases
27Lamivudine
28Lamivudine - therapeutic use
29Lopinavir - therapeutic use
30Male
31Medical sciences
32Middle Aged
33Mutation
34Nucleosides
35Patients
36Pharmacology. Drug treatments
37Reverse Transcriptase Inhibitors - therapeutic use
38Ritonavir - therapeutic use
39Viral diseases
40Viral diseases of the lymphoid tissue and the blood. Aids
41Young Adult
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titleDual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial
authorCahn, Pedro, Dr ; Andrade-Villanueva, Jaime, MD ; Arribas, José R, MD ; Gatell, José M, MD ; Lama, Javier R, MD ; Norton, Michael, MD ; Patterson, Patricia, MD ; Madero, Juan Sierra, MD ; Sued, Omar, MD ; Figueroa, Maria Inés, MD ; Rolon, Maria José, MD
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4Antibiotics. Antiinfectious agents. Antiparasitic agents
5Antiretroviral drugs
6Antiretroviral Therapy, Highly Active - methods
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8Biological and medical sciences
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39Viral diseases
40Viral diseases of the lymphoid tissue and the blood. Aids
41Young Adult
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atitleDual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial
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abstractSummary Background Daily oral triple therapy is effective at halting HIV disease progression, but can have toxic effects and is costly. We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy. Methods The GARDEL study (Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy) is a 48 week, phase 3, randomised, controlled, open-label, non-inferiority trial in antiretroviral-therapy-naive adults (age ≥18 years) with documented HIV-1 RNA viral load of at least 1000 copies per mL. The study was done at 19 centres in six countries. Patients were randomly assigned (1:1) to dual therapy or triple therapy by sealed envelopes, in blocks of four, stratified by baseline viral load (<100 000 vs ≥100 000 copies per mL). Dual therapy consisted of lopinavir 400 mg and ritonavir 100 mg plus lamivudine 150 mg, both twice daily. Triple therapy consisted of lopinavir 400 mg and ritonavir 100 mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor (NRTI) in fixed-dose combination. Efficacy was analysed in all participants who received at least one dose of study drug. The primary endpoint was virological response rate, defined as the proportion of patients with HIV RNA less than 50 copies per mL at 48 weeks. Dual therapy was classed as non-inferior to triple therapy if the lower bound of the 95% CI for the difference between groups was no lower than −12%. Patients and investigators were unmasked to treatment allocation. This study is registered with ClinicalTrials.gov , number NCT01237444. Findings Between Dec 10, 2010, and May 15, 2012, 217 patients were randomly assigned to the dual-therapy group and 209 to the triple-therapy group. 198 patients in the dual-therapy group and 175 in the triple-therapy group completed 48 weeks of treatment. At week 48, 189 patients (88·3%) in the dual-therapy group and 169 (83·7%) in the triple-therapy group had viral response (difference 4·6%, 95% CI −2·2 to 11·8; p=0·171). Patients with baseline viral load of at least 100 000 copies per mL showed similar results (87·2% vs 77·9%, respectively; difference 9·3%, 95% CI −2·8 to 21·5; p=0·145). Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group (n=10 [4·9%]) than in the dual-therapy group (n=1 [0·4%]; difference 4·5%, 95% CI −8·1 to −0·9; p=0·011). 65 adverse events in the dual-therapy group and 88 in the triple-therapy group were possibly or probably drug related (p=0·007). Two serious adverse events occurred, both in the dual-therapy arm, one of which (a case of gastritis) was reported as possibly or probably related to drug treatment. Interpretation Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients. Funding Fundación Huésped and AbbVie.
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pubElsevier Ltd
pmid24783988
doi10.1016/S1473-3099(14)70736-4