A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to that of Nystatin Oral Suspension for the Treatment of OC in HIV-1 Infected Participants in Non-US Settings
Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental Craniofacial Research (NIDCR)
Protocol Summary: A5265 is a phase III, open-label, randomized, assessment-blinded clinical trial in non-U.S. sites to compare the safety and efficacy of topical gentian violet (GV) to that of oral nystatin. Therapy will be considered as failed if participants have no clinical improvement (assessed by severity and extent of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of oral candidiasis (OC) will be done by an evaluator who is blinded to treatment assignment. Quantification of colony forming units (CFUs) of Candida species (spp.) and assessment of the emergence of resistance will be performed using an oropharyngeal swab and a second specimen from oral rinse/throat wash will be collected and stored for future testing.
Years: 2011 – 2014
Investigator: James Hakim, MBChB, FRCP
Location: Parirenyatwa CRS