Dual treatment with lopinavir–ritonavir plus lamivudine versus triple treatment with lopinavir–ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial
Summary Background Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir–ritonavir and lamivudine to triple treatment with lopinavir–ritonavir plus two nucleos(t)ides for maintenance of HIV-1 viral suppression. Methods In this randomised, open-label, non-inferiorit...
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| Veröffentlicht in: | The Lancet infectious diseases 2015-07, Vol.15 (7), p.785-792 |
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| creator | Arribas, José R, Dr Girard, Pierre-Marie, MD Landman, Roland, MD Pich, Judit, PharmD Mallolas, Josep, MD Martínez-Rebollar, María, MD Zamora, Francisco X, MD Estrada, Vicente, MD Crespo, Manuel, MD Podzamczer, Daniel, MD Portilla, Joaquín, MD Dronda, Fernando, MD Iribarren, José A, MD Domingo, Pere, MD Pulido, Federico, MD Montero, Marta, MD Knobel, Hernando, MD Cabié, André, Prof Weiss, Laurence, Prof Gatell, José M, Prof |
| description | Summary Background Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir–ritonavir and lamivudine to triple treatment with lopinavir–ritonavir plus two nucleos(t)ides for maintenance of HIV-1 viral suppression. Methods In this randomised, open-label, non-inferiority trial, we recruited patients from 32 HIV units in hospitals in Spain and France. Eligible patients were HIV-infected adults (aged ≥18 years) with HIV-1 RNA of less than 50 copies per mL, for at least 6 months on triple treatment with lopinavir–ritonavir (twice daily) plus lamivudine or emtricitabine and a second nucleos(t)ide, with no resistance or virological failure to these drugs, and no positive hepatitis B serum surface antigen. Investigators at each centre randomly assigned patients (1:1; block size of four; stratified by time to suppression [1 year] and nadir CD4 cell count [100 cells per μL]; computer-generated random sequence) to continue triple treatment or switch to dual treatment (oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily). The primary endpoint was response to treatment in the intention-to-treat population (all randomised patients) at 48 weeks. The non-inferiority margin was 12%. This study is registered with ClinicalTrials.gov , number NCT01471821. Findings Between Oct 1, 2011, and April 1, 2013, we randomly assigned 250 participants to continue triple treatment (127 [51%] patients) or switch to dual treatment (123 [49%] patients). In the intention-to-treat population, 110 (86·6%) of 127 patients in the triple-treatment group responded to treatment versus 108 (87·8%) of 123 in the dual-treatment group (difference −1·2% [95% CI −9·6 to 7·3]; p=0·92), meeting the criteria for non-inferiority. Serious adverse events occurred in eight (7%) patients in the triple-treatment group and five (4%) in the dual-treatment group (p=0·515), and study drug discontinuations due to adverse events occurred in four (3%) in the triple-treatment group and one (1%) in the dual-treatment group (p=0·223). Interpretation Dual treatment with lopinavir–ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment. Funding AbbVie and Red Temática Cooperativa de Investigación en Sida. |
| doi_str_mv | 10.1016/S1473-3099(15)00096-1 |
| format | Article |
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Methods In this randomised, open-label, non-inferiority trial, we recruited patients from 32 HIV units in hospitals in Spain and France. Eligible patients were HIV-infected adults (aged ≥18 years) with HIV-1 RNA of less than 50 copies per mL, for at least 6 months on triple treatment with lopinavir–ritonavir (twice daily) plus lamivudine or emtricitabine and a second nucleos(t)ide, with no resistance or virological failure to these drugs, and no positive hepatitis B serum surface antigen. Investigators at each centre randomly assigned patients (1:1; block size of four; stratified by time to suppression [<1 year or >1 year] and nadir CD4 cell count [<100 cells per μL or >100 cells per μL]; computer-generated random sequence) to continue triple treatment or switch to dual treatment (oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily). The primary endpoint was response to treatment in the intention-to-treat population (all randomised patients) at 48 weeks. The non-inferiority margin was 12%. This study is registered with ClinicalTrials.gov , number NCT01471821. Findings Between Oct 1, 2011, and April 1, 2013, we randomly assigned 250 participants to continue triple treatment (127 [51%] patients) or switch to dual treatment (123 [49%] patients). In the intention-to-treat population, 110 (86·6%) of 127 patients in the triple-treatment group responded to treatment versus 108 (87·8%) of 123 in the dual-treatment group (difference −1·2% [95% CI −9·6 to 7·3]; p=0·92), meeting the criteria for non-inferiority. Serious adverse events occurred in eight (7%) patients in the triple-treatment group and five (4%) in the dual-treatment group (p=0·515), and study drug discontinuations due to adverse events occurred in four (3%) in the triple-treatment group and one (1%) in the dual-treatment group (p=0·223). Interpretation Dual treatment with lopinavir–ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment. Funding AbbVie and Red Temática Cooperativa de Investigación en Sida.</description><identifier>ISSN: 1473-3099</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(15)00096-1</identifier><identifier>PMID: 26062880</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; CD4 Lymphocyte Count ; Clinical trials ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Drug Therapy, Combination - adverse effects ; Drug Therapy, Combination - methods ; Emtricitabine ; Female ; Hepatitis B virus ; HIV ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - virology ; HIV Protease Inhibitors - adverse effects ; HIV Protease Inhibitors - therapeutic use ; HIV-1 ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Humans ; Infectious Disease ; Infectious diseases ; Intention to Treat Analysis ; Laboratories ; Lamivudine - therapeutic use ; Lopinavir - therapeutic use ; Maintenance Chemotherapy ; Male ; Middle Aged ; Public health ; Reverse Transcriptase Inhibitors - adverse effects ; Reverse Transcriptase Inhibitors - therapeutic use ; Ritonavir ; Ritonavir - therapeutic use ; RNA, Viral - blood ; Substance abuse treatment ; Viral Load</subject><ispartof>The Lancet infectious diseases, 2015-07, Vol.15 (7), p.785-792</ispartof><rights>Elsevier Ltd</rights><rights>2015 Elsevier Ltd</rights><rights>Copyright © 2015 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jul 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c603t-ccbd4f8cd17313127fda09e01ec8de13034828d96957a26961915fff581573a63</citedby><cites>FETCH-LOGICAL-c603t-ccbd4f8cd17313127fda09e01ec8de13034828d96957a26961915fff581573a63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309915000961$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26062880$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Arribas, José R, Dr</creatorcontrib><creatorcontrib>Girard, Pierre-Marie, MD</creatorcontrib><creatorcontrib>Landman, Roland, MD</creatorcontrib><creatorcontrib>Pich, Judit, PharmD</creatorcontrib><creatorcontrib>Mallolas, Josep, MD</creatorcontrib><creatorcontrib>Martínez-Rebollar, María, MD</creatorcontrib><creatorcontrib>Zamora, Francisco X, MD</creatorcontrib><creatorcontrib>Estrada, Vicente, MD</creatorcontrib><creatorcontrib>Crespo, Manuel, MD</creatorcontrib><creatorcontrib>Podzamczer, Daniel, MD</creatorcontrib><creatorcontrib>Portilla, Joaquín, MD</creatorcontrib><creatorcontrib>Dronda, Fernando, MD</creatorcontrib><creatorcontrib>Iribarren, José A, MD</creatorcontrib><creatorcontrib>Domingo, Pere, MD</creatorcontrib><creatorcontrib>Pulido, Federico, MD</creatorcontrib><creatorcontrib>Montero, Marta, MD</creatorcontrib><creatorcontrib>Knobel, Hernando, MD</creatorcontrib><creatorcontrib>Cabié, André, Prof</creatorcontrib><creatorcontrib>Weiss, Laurence, Prof</creatorcontrib><creatorcontrib>Gatell, José M, Prof</creatorcontrib><creatorcontrib>OLE/RIS-EST13 Study Group</creatorcontrib><title>Dual treatment with lopinavir–ritonavir plus lamivudine versus triple treatment with lopinavir–ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>Summary Background Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir–ritonavir and lamivudine to triple treatment with lopinavir–ritonavir plus two nucleos(t)ides for maintenance of HIV-1 viral suppression. Methods In this randomised, open-label, non-inferiority trial, we recruited patients from 32 HIV units in hospitals in Spain and France. Eligible patients were HIV-infected adults (aged ≥18 years) with HIV-1 RNA of less than 50 copies per mL, for at least 6 months on triple treatment with lopinavir–ritonavir (twice daily) plus lamivudine or emtricitabine and a second nucleos(t)ide, with no resistance or virological failure to these drugs, and no positive hepatitis B serum surface antigen. Investigators at each centre randomly assigned patients (1:1; block size of four; stratified by time to suppression [<1 year or >1 year] and nadir CD4 cell count [<100 cells per μL or >100 cells per μL]; computer-generated random sequence) to continue triple treatment or switch to dual treatment (oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily). The primary endpoint was response to treatment in the intention-to-treat population (all randomised patients) at 48 weeks. The non-inferiority margin was 12%. This study is registered with ClinicalTrials.gov , number NCT01471821. Findings Between Oct 1, 2011, and April 1, 2013, we randomly assigned 250 participants to continue triple treatment (127 [51%] patients) or switch to dual treatment (123 [49%] patients). In the intention-to-treat population, 110 (86·6%) of 127 patients in the triple-treatment group responded to treatment versus 108 (87·8%) of 123 in the dual-treatment group (difference −1·2% [95% CI −9·6 to 7·3]; p=0·92), meeting the criteria for non-inferiority. Serious adverse events occurred in eight (7%) patients in the triple-treatment group and five (4%) in the dual-treatment group (p=0·515), and study drug discontinuations due to adverse events occurred in four (3%) in the triple-treatment group and one (1%) in the dual-treatment group (p=0·223). Interpretation Dual treatment with lopinavir–ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment. Funding AbbVie and Red Temática Cooperativa de Investigación en Sida.</description><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>CD4 Lymphocyte Count</subject><subject>Clinical trials</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Drug Therapy, Combination - adverse effects</subject><subject>Drug Therapy, Combination - methods</subject><subject>Emtricitabine</subject><subject>Female</subject><subject>Hepatitis B virus</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - virology</subject><subject>HIV Protease Inhibitors - adverse effects</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Human immunodeficiency virus 1</subject><subject>Humans</subject><subject>Infectious Disease</subject><subject>Infectious diseases</subject><subject>Intention to Treat Analysis</subject><subject>Laboratories</subject><subject>Lamivudine - 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adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral drugs</topic><topic>CD4 Lymphocyte Count</topic><topic>Clinical trials</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Drug Therapy, Combination - adverse effects</topic><topic>Drug Therapy, Combination - methods</topic><topic>Emtricitabine</topic><topic>Female</topic><topic>Hepatitis B virus</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - virology</topic><topic>HIV Protease Inhibitors - adverse effects</topic><topic>HIV Protease Inhibitors - therapeutic use</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Human immunodeficiency virus 1</topic><topic>Humans</topic><topic>Infectious Disease</topic><topic>Infectious diseases</topic><topic>Intention to Treat Analysis</topic><topic>Laboratories</topic><topic>Lamivudine - therapeutic use</topic><topic>Lopinavir - therapeutic use</topic><topic>Maintenance Chemotherapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Public health</topic><topic>Reverse Transcriptase Inhibitors - adverse effects</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>Ritonavir</topic><topic>Ritonavir - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>Substance abuse treatment</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Arribas, José R, Dr</creatorcontrib><creatorcontrib>Girard, Pierre-Marie, MD</creatorcontrib><creatorcontrib>Landman, Roland, MD</creatorcontrib><creatorcontrib>Pich, Judit, PharmD</creatorcontrib><creatorcontrib>Mallolas, Josep, MD</creatorcontrib><creatorcontrib>Martínez-Rebollar, María, MD</creatorcontrib><creatorcontrib>Zamora, Francisco X, MD</creatorcontrib><creatorcontrib>Estrada, Vicente, MD</creatorcontrib><creatorcontrib>Crespo, Manuel, MD</creatorcontrib><creatorcontrib>Podzamczer, Daniel, MD</creatorcontrib><creatorcontrib>Portilla, Joaquín, MD</creatorcontrib><creatorcontrib>Dronda, Fernando, MD</creatorcontrib><creatorcontrib>Iribarren, José A, MD</creatorcontrib><creatorcontrib>Domingo, Pere, MD</creatorcontrib><creatorcontrib>Pulido, Federico, MD</creatorcontrib><creatorcontrib>Montero, Marta, MD</creatorcontrib><creatorcontrib>Knobel, Hernando, MD</creatorcontrib><creatorcontrib>Cabié, André, Prof</creatorcontrib><creatorcontrib>Weiss, Laurence, Prof</creatorcontrib><creatorcontrib>Gatell, José M, Prof</creatorcontrib><creatorcontrib>OLE/RIS-EST13 Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>Nucleic Acids Abstracts</collection><jtitle>The Lancet infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Arribas, José R, Dr</au><au>Girard, Pierre-Marie, MD</au><au>Landman, Roland, MD</au><au>Pich, Judit, PharmD</au><au>Mallolas, Josep, MD</au><au>Martínez-Rebollar, María, MD</au><au>Zamora, Francisco X, MD</au><au>Estrada, Vicente, MD</au><au>Crespo, Manuel, MD</au><au>Podzamczer, Daniel, MD</au><au>Portilla, Joaquín, MD</au><au>Dronda, Fernando, MD</au><au>Iribarren, José A, MD</au><au>Domingo, Pere, MD</au><au>Pulido, Federico, MD</au><au>Montero, Marta, MD</au><au>Knobel, Hernando, MD</au><au>Cabié, André, Prof</au><au>Weiss, Laurence, Prof</au><au>Gatell, José M, Prof</au><aucorp>OLE/RIS-EST13 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dual treatment with lopinavir–ritonavir plus lamivudine versus triple treatment with lopinavir–ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial</atitle><jtitle>The Lancet infectious diseases</jtitle><addtitle>Lancet Infect Dis</addtitle><date>2015-07-01</date><risdate>2015</risdate><volume>15</volume><issue>7</issue><spage>785</spage><epage>792</epage><pages>785-792</pages><issn>1473-3099</issn><eissn>1474-4457</eissn><coden>LANCAO</coden><abstract>Summary Background Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir–ritonavir and lamivudine to triple treatment with lopinavir–ritonavir plus two nucleos(t)ides for maintenance of HIV-1 viral suppression. Methods In this randomised, open-label, non-inferiority trial, we recruited patients from 32 HIV units in hospitals in Spain and France. Eligible patients were HIV-infected adults (aged ≥18 years) with HIV-1 RNA of less than 50 copies per mL, for at least 6 months on triple treatment with lopinavir–ritonavir (twice daily) plus lamivudine or emtricitabine and a second nucleos(t)ide, with no resistance or virological failure to these drugs, and no positive hepatitis B serum surface antigen. Investigators at each centre randomly assigned patients (1:1; block size of four; stratified by time to suppression [<1 year or >1 year] and nadir CD4 cell count [<100 cells per μL or >100 cells per μL]; computer-generated random sequence) to continue triple treatment or switch to dual treatment (oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily). The primary endpoint was response to treatment in the intention-to-treat population (all randomised patients) at 48 weeks. The non-inferiority margin was 12%. This study is registered with ClinicalTrials.gov , number NCT01471821. Findings Between Oct 1, 2011, and April 1, 2013, we randomly assigned 250 participants to continue triple treatment (127 [51%] patients) or switch to dual treatment (123 [49%] patients). In the intention-to-treat population, 110 (86·6%) of 127 patients in the triple-treatment group responded to treatment versus 108 (87·8%) of 123 in the dual-treatment group (difference −1·2% [95% CI −9·6 to 7·3]; p=0·92), meeting the criteria for non-inferiority. Serious adverse events occurred in eight (7%) patients in the triple-treatment group and five (4%) in the dual-treatment group (p=0·515), and study drug discontinuations due to adverse events occurred in four (3%) in the triple-treatment group and one (1%) in the dual-treatment group (p=0·223). Interpretation Dual treatment with lopinavir–ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment. Funding AbbVie and Red Temática Cooperativa de Investigación en Sida.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>26062880</pmid><doi>10.1016/S1473-3099(15)00096-1</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1473-3099 |
| ispartof | The Lancet infectious diseases, 2015-07, Vol.15 (7), p.785-792 |
| issn | 1473-3099 1474-4457 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1717490583 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Antiretroviral drugs CD4 Lymphocyte Count Clinical trials Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Drug Therapy, Combination - adverse effects Drug Therapy, Combination - methods Emtricitabine Female Hepatitis B virus HIV HIV Infections - drug therapy HIV Infections - immunology HIV Infections - virology HIV Protease Inhibitors - adverse effects HIV Protease Inhibitors - therapeutic use HIV-1 Human immunodeficiency virus Human immunodeficiency virus 1 Humans Infectious Disease Infectious diseases Intention to Treat Analysis Laboratories Lamivudine - therapeutic use Lopinavir - therapeutic use Maintenance Chemotherapy Male Middle Aged Public health Reverse Transcriptase Inhibitors - adverse effects Reverse Transcriptase Inhibitors - therapeutic use Ritonavir Ritonavir - therapeutic use RNA, Viral - blood Substance abuse treatment Viral Load |
| title | Dual treatment with lopinavir–ritonavir plus lamivudine versus triple treatment with lopinavir–ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial |
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