Topical gentian violet compared to nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 Infected participants.
AIDS. 2016 Sep 24;
Authors: Mukherjee PK, Chen H, Patton LL, Evans S, Lee A, Kumwenda J, Hakim J, Masheto G, Sawe F, Pho MT, Freedberg KA, Shiboski CH, Ghannoum MA, Salata RA, and the Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team
OBJECTIVE: Compare the safety and efficacy of topical gentian violet (GV) to that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis (OC) in HIV-1 infected adults in resource-limited settings.
DESIGN: Multicenter, open-label, evaluator-blinded, randomized clinical trial at 8 international sites, within the AIDS Clinical Trials Group.
STUDY PARTICIPANTS AND INTERVENTION: Adult HIV-infected participants with OC, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either GV (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 OC were evaluated in an evaluator-blinded manner.
RESULTS: The study was closed early per DSMB after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the GV arm had cure or improvement of OC versus 61 (67.8%) in the NYS arm, resulting in a non-sizable difference of 0.007 (95% CI: -0.129, 0.143). There was no sizable difference in cure rates between the two arms (-0.0007; 95% CI: -0.146, 0.131). No GV-related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In GV arm, 61% and 39% of participants reported "no" and "mild-to-moderate" staining, respectively. Cost for medication procurement was significantly lower for GV versus NYS [Median $2.51 and $19.42, respectively, P = 0.01].
CONCLUSIONS: Efficacy of GV was not statistically different than NYS, was well-tolerated, and its procurement cost was substantially less than NYS.
PMID: 27677161 [PubMed - as supplied by publisher]