Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants.
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.



Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group.



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.



Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner.



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).



Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.
Division of Infectious Diseases & HIV Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
Pranab K
PK
Mukherjee
Huichao
H
Chen
Lauren L
LL
Patton
Scott
S
Evans
Anthony
A
Lee
Johnstone
J
Kumwenda
James
J
Hakim
Gaerolwe
G
Masheto
Frederick
F
Sawe
Mai T
MT
Pho
Kenneth A
KA
Freedberg
Caroline H
CH
Shiboski
Mahmoud A
MA
Ghannoum
Robert A
RA
Salata
D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005840:Gentian Violet / Q000008:administration & dosage* / Q000009:adverse effects; D015658:HIV Infections / Q000150:complications*; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D009761:Nystatin / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D009761:Nystatin; D005840:Gentian Violet
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