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
Hauptverfasser: 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
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container_end_page 88
container_issue 1
container_start_page 81
container_title AIDS (London)
container_volume 31
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
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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 &amp; dosage ; Antifungal Agents - adverse effects ; Candidiasis, Oral - drug therapy ; Candidiasis, Oral - pathology ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Female ; Gentian Violet - administration &amp; dosage ; Gentian Violet - adverse effects ; Health Care Costs ; HIV Infections - complications ; Humans ; Lentivirus ; Male ; Middle Aged ; Nystatin - administration &amp; 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. 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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). 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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 ; 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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 &amp; 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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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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