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

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.

• Authors: Pranab K Mukherjee, Huichao Chen, Lauren L Patton, Scott Evans, Anthony Lee, Johnstone Kumwenda, James Hakim, Gaerolwe Masheto, Frederick Sawe, Mai T Pho, Kenneth A Freedberg, Caroline H Shiboski, Mahmoud A Ghannoum, Robert A Salata, Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team
• Journal: AIDS (London, England) (AIDS) Vol. 31 Issue 1 Pg. 81-88 (01 02 2017) ISSN: 1473-5571 [Electronic] England
• PMID: 27677161 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Extramural)

Chemical References

• Antifungal Agents
• Nystatin
• Gentian Violet

Topics

• Administration, Oral
• Administration, Topical
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, adverse effects)
• Candidiasis, Oral (drug therapy, pathology)
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Gentian Violet (administration & dosage, adverse effects)
• HIV Infections (complications)
• Health Care Costs
• Humans
• Male
• Middle Aged
• Nystatin (administration & dosage, adverse effects)
• Single-Blind Method
• Treatment Outcome
• Young Adult