Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants
OBJECTIVE:Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings. DESIGN:Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight...
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Veröffentlicht in: | AIDS (London) 2017-01, Vol.31 (1), p.81-88 |
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creator | Mukherjee, Pranab K Chen, Huichao Patton, Lauren L Evans, Scott Lee, Anthony Kumwenda, Johnstone Hakim, James Masheto, Gaerolwe Sawe, Frederick Pho, Mai T Freedberg, Kenneth A Shiboski, Caroline H Ghannoum, Mahmoud A Salata, Robert A |
description | OBJECTIVE:Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings.
DESIGN:Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group.
STUDY PARTICIPANTS AND INTERVENTION:Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days.
MAIN OUTCOME MEASURE(S):Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner.
RESULTS:The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval−0.129, 0.143). There was no sizable difference in cure rates between the two arms (−0.0007; 95% confidence interval−0.146, 0.131). No gentian violet–related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported ‘no’ and ‘mild-to-moderate’ staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01).
CONCLUSION:Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS. |
doi_str_mv | 10.1097/QAD.0000000000001286 |
format | Article |
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DESIGN:Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group.
STUDY PARTICIPANTS AND INTERVENTION:Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days.
MAIN OUTCOME MEASURE(S):Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner.
RESULTS:The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval−0.129, 0.143). There was no sizable difference in cure rates between the two arms (−0.0007; 95% confidence interval−0.146, 0.131). No gentian violet–related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported ‘no’ and ‘mild-to-moderate’ staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01).
CONCLUSION:Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.</description><identifier>ISSN: 0269-9370</identifier><identifier>EISSN: 1473-5571</identifier><identifier>DOI: 10.1097/QAD.0000000000001286</identifier><identifier>PMID: 27677161</identifier><language>eng</language><publisher>England: Copyright Wolters Kluwer Health, Inc</publisher><subject>Administration, Oral ; Administration, Topical ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; AIDS/HIV ; Antifungal Agents - administration & dosage ; Antifungal Agents - adverse effects ; Candidiasis, Oral - drug therapy ; Candidiasis, Oral - pathology ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Female ; Gentian Violet - administration & dosage ; Gentian Violet - adverse effects ; Health Care Costs ; HIV Infections - complications ; Humans ; Lentivirus ; Male ; Middle Aged ; Nystatin - administration & dosage ; Nystatin - adverse effects ; Retroviridae ; Single-Blind Method ; Treatment Outcome ; Young Adult</subject><ispartof>AIDS (London), 2017-01, Vol.31 (1), p.81-88</ispartof><rights>Copyright © 2017 Wolters Kluwer Health, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4806-e13e57f85ad736cedfdbf981f9db04afedb3aeb9c9c4e11c1f890f93b4c897173</citedby><cites>FETCH-LOGICAL-c4806-e13e57f85ad736cedfdbf981f9db04afedb3aeb9c9c4e11c1f890f93b4c897173</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27677161$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mukherjee, Pranab K</creatorcontrib><creatorcontrib>Chen, Huichao</creatorcontrib><creatorcontrib>Patton, Lauren L</creatorcontrib><creatorcontrib>Evans, Scott</creatorcontrib><creatorcontrib>Lee, Anthony</creatorcontrib><creatorcontrib>Kumwenda, Johnstone</creatorcontrib><creatorcontrib>Hakim, James</creatorcontrib><creatorcontrib>Masheto, Gaerolwe</creatorcontrib><creatorcontrib>Sawe, Frederick</creatorcontrib><creatorcontrib>Pho, Mai T</creatorcontrib><creatorcontrib>Freedberg, Kenneth A</creatorcontrib><creatorcontrib>Shiboski, Caroline H</creatorcontrib><creatorcontrib>Ghannoum, Mahmoud A</creatorcontrib><creatorcontrib>Salata, Robert A</creatorcontrib><creatorcontrib>Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team</creatorcontrib><title>Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants</title><title>AIDS (London)</title><addtitle>AIDS</addtitle><description>OBJECTIVE:Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings.
DESIGN:Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group.
STUDY PARTICIPANTS AND INTERVENTION:Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days.
MAIN OUTCOME MEASURE(S):Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner.
RESULTS:The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval−0.129, 0.143). There was no sizable difference in cure rates between the two arms (−0.0007; 95% confidence interval−0.146, 0.131). No gentian violet–related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported ‘no’ and ‘mild-to-moderate’ staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01).
CONCLUSION:Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.</description><subject>Administration, Oral</subject><subject>Administration, Topical</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>AIDS/HIV</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - adverse effects</subject><subject>Candidiasis, Oral - drug therapy</subject><subject>Candidiasis, Oral - pathology</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Female</subject><subject>Gentian Violet - administration & dosage</subject><subject>Gentian Violet - adverse effects</subject><subject>Health Care Costs</subject><subject>HIV Infections - complications</subject><subject>Humans</subject><subject>Lentivirus</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nystatin - administration & dosage</subject><subject>Nystatin - adverse effects</subject><subject>Retroviridae</subject><subject>Single-Blind Method</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0269-9370</issn><issn>1473-5571</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1vFSEUhonR2Gv1HxjD0g0VhpkBlk39aJMmxqS6nTBw6KAzMALjTX-Df1pubjXGhcoGQp73Ocl5EXrO6BmjSrz6cP76jP52WCP7B2jHWsFJ1wn2EO1o0yuiuKAn6EnOnyvUUSkfo5NG9EKwnu3Q95u4eqNnfAuheB3wNx9nKNjEZdUJLN77MuFwl4suPuCYKpq3vELIPgbsYsJlAlwS6LJUBY6uQnGddLoLt1Bpo4P11uvsM66Gy6tPhBEfHJhS9XVI8cavOpT8FD1yes7w7P4-RR_fvrm5uCTX799dXZxfE9NK2hNgHDrhZKet4L0B6-zolGRO2ZG22oEduYZRGWVaYMwwJxV1io-tkUowwU_Ry6N3TfHrBrkMi88G5lkHiFsemOwlb7hqu_9AeddRrsQBbY-oSTHnBG5Yk1_qGgZGh0NjQ21s-LOxGntxP2EbF7C_Qj8rqoA8Avs4F0j5y7ztIQ1T3W2Z_uVu_xI9YA3llDSUCcrqmxy-FP8Bf321VA</recordid><startdate>20170102</startdate><enddate>20170102</enddate><creator>Mukherjee, Pranab K</creator><creator>Chen, Huichao</creator><creator>Patton, Lauren L</creator><creator>Evans, Scott</creator><creator>Lee, Anthony</creator><creator>Kumwenda, Johnstone</creator><creator>Hakim, James</creator><creator>Masheto, Gaerolwe</creator><creator>Sawe, Frederick</creator><creator>Pho, Mai T</creator><creator>Freedberg, Kenneth A</creator><creator>Shiboski, Caroline H</creator><creator>Ghannoum, Mahmoud A</creator><creator>Salata, Robert A</creator><general>Copyright Wolters Kluwer Health, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T2</scope><scope>7T5</scope><scope>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20170102</creationdate><title>Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants</title><author>Mukherjee, Pranab K ; Chen, Huichao ; Patton, Lauren L ; Evans, Scott ; Lee, Anthony ; Kumwenda, Johnstone ; Hakim, James ; Masheto, Gaerolwe ; Sawe, Frederick ; Pho, Mai T ; Freedberg, Kenneth A ; Shiboski, Caroline H ; Ghannoum, Mahmoud A ; Salata, Robert A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4806-e13e57f85ad736cedfdbf981f9db04afedb3aeb9c9c4e11c1f890f93b4c897173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Administration, Oral</topic><topic>Administration, Topical</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>AIDS/HIV</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - adverse effects</topic><topic>Candidiasis, Oral - drug therapy</topic><topic>Candidiasis, Oral - pathology</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Female</topic><topic>Gentian Violet - administration & dosage</topic><topic>Gentian Violet - adverse effects</topic><topic>Health Care Costs</topic><topic>HIV Infections - complications</topic><topic>Humans</topic><topic>Lentivirus</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nystatin - administration & dosage</topic><topic>Nystatin - adverse effects</topic><topic>Retroviridae</topic><topic>Single-Blind Method</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mukherjee, Pranab K</creatorcontrib><creatorcontrib>Chen, Huichao</creatorcontrib><creatorcontrib>Patton, Lauren L</creatorcontrib><creatorcontrib>Evans, Scott</creatorcontrib><creatorcontrib>Lee, Anthony</creatorcontrib><creatorcontrib>Kumwenda, Johnstone</creatorcontrib><creatorcontrib>Hakim, James</creatorcontrib><creatorcontrib>Masheto, Gaerolwe</creatorcontrib><creatorcontrib>Sawe, Frederick</creatorcontrib><creatorcontrib>Pho, Mai T</creatorcontrib><creatorcontrib>Freedberg, Kenneth A</creatorcontrib><creatorcontrib>Shiboski, Caroline H</creatorcontrib><creatorcontrib>Ghannoum, Mahmoud A</creatorcontrib><creatorcontrib>Salata, Robert A</creatorcontrib><creatorcontrib>Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>AIDS (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mukherjee, Pranab K</au><au>Chen, Huichao</au><au>Patton, Lauren L</au><au>Evans, Scott</au><au>Lee, Anthony</au><au>Kumwenda, Johnstone</au><au>Hakim, James</au><au>Masheto, Gaerolwe</au><au>Sawe, Frederick</au><au>Pho, Mai T</au><au>Freedberg, Kenneth A</au><au>Shiboski, Caroline H</au><au>Ghannoum, Mahmoud A</au><au>Salata, Robert A</au><aucorp>Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants</atitle><jtitle>AIDS (London)</jtitle><addtitle>AIDS</addtitle><date>2017-01-02</date><risdate>2017</risdate><volume>31</volume><issue>1</issue><spage>81</spage><epage>88</epage><pages>81-88</pages><issn>0269-9370</issn><eissn>1473-5571</eissn><abstract>OBJECTIVE:Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings.
DESIGN:Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group.
STUDY PARTICIPANTS AND INTERVENTION:Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days.
MAIN OUTCOME MEASURE(S):Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner.
RESULTS:The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval−0.129, 0.143). There was no sizable difference in cure rates between the two arms (−0.0007; 95% confidence interval−0.146, 0.131). No gentian violet–related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported ‘no’ and ‘mild-to-moderate’ staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01).
CONCLUSION:Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.</abstract><cop>England</cop><pub>Copyright Wolters Kluwer Health, Inc</pub><pmid>27677161</pmid><doi>10.1097/QAD.0000000000001286</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Journals@Ovid Complete; EZB-FREE-00999 freely available EZB journals |
subjects | Administration, Oral Administration, Topical Adolescent Adult Aged Aged, 80 and over AIDS/HIV Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Candidiasis, Oral - drug therapy Candidiasis, Oral - pathology Drug-Related Side Effects and Adverse Reactions - epidemiology Female Gentian Violet - administration & dosage Gentian Violet - adverse effects Health Care Costs HIV Infections - complications Humans Lentivirus Male Middle Aged Nystatin - administration & dosage Nystatin - adverse effects Retroviridae Single-Blind Method Treatment Outcome Young Adult |
title | Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants |
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