Oral candidiasis (OC) is among the most common opportunistic infections observed in HIV infected individuals. This study compares the safety and efficacy of topical GV (0.00165%) to that of oral nystatin suspension. HIV-1 positive participants’ ≥ 18 years of age will be randomly assigned to receive either topical GV solution (5 mL swish and gargle for 2 minutes and spit BID) or nystatin oral suspension (5 mL swish for 2 minutes and swallow QID) for 14 days. Therapy will be considered as failed if participants have no clinical improvement (assessed by severity of  candidiasis) during either treatment regimen.

Oral candidiasis (OC) is among the most common opportunistic infections observed in HIV infected individuals. OC tends to occur in about 60%of patients with a CD4+T-cell count of <200cells/mm³and of these, more than half experience recurrence. Current criteria in the choice of treatment for OC is determined by availability and affordability of medications within a particular clinical setting or based on specified institutional or national guidelines. Kenya’s Ministry of Health guideline on management of OC recommends use of Gentian violet (0.5-1%), nystatin oral suspension, and clotrimazole cream while fluconazole and ketoconazole is recommended for systemic therapy when there is no improvement with topical preparations.   Gentian violet (GV) 0.5-1% has been used; though rarely due to stigma of discoloration of the oral cavity despite GV being cheaper, easy to use and store.  This study compares the safety and efficacy of topical GV (0.00165%) to that of oral nystatin suspension. HIV-1 positive participants’ ≥ 18 years of age will be randomized to receive either topical GV solution (5 mL swish and gargle for 2 minutes and spit BID) or nystatin oral suspension (5 mL swish for 2 minutes and swallow QID) for 14 days. Therapy will be considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of OC will be done by an evaluator who is blinded to the treatment assignment. Participants who are failing treatment after the study-defined 14-day treatment regimen will be referred to their primary physician for care and treatment outside of the study, but will continue to be followed on study. Quantification of Colony Forming Units (CFUs) of Candida species (ssp.) and assessment of the emergence of resistance will be performed using an oropharyngeal swab and a second specimen from oral rinse will be collected and stored for future testing.The Kericho site will recruit about 40-80  participants who present with OC as evidenced by pseudomembranous candidiasis. Recruitment will be primarily done through Kericho District Hospital HIV clinic. All enrolled participants will be followed up for 13 weeks. The site accrual rate is estimated to be 10 participants per month; hence estimated duration of accrual is 4-8months. If GV is shown to be superior to nystatin in the treatment of OC, an effective low-cost therapy would then be readily available to patients who cannot afford more expensive therapy. This may be particularly relevant in resource-limited settings where the cost of therapy poses a serious challenge for patients as well as for treating physicians.