Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. (2nd January 2017)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: AIDS. Volume 31:Number 1(2017)
• Publication Date: 2017-01-02
• Subjects: cost per treatment -- gentian violet -- nystatin -- oral candidiasis -- oral complications in HIV infection -- resource-limited setting; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome; AIDS (Disease); Periodicals; Periodicals; 616.9792005
• DOI: 10.1097/QAD.0000000000001286
• Languages: English
• ISSNs: 0269-9370

Abstract

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 : Supplemental Digital Content is available in the text