Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Phase 3 Completed 221 enrolled Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to see which one of two medicines (topical gentian violet \[GV\] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.

Timeline

Start: 2011-06
Primary completion: 2012-09
Completion: 2014-01

Publications

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; Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team. Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. AIDS. 2017 Jan 2;31(1):81-88. doi: 10.1097/QAD.0000000000001286.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HEXAMETHYL PARAROSANILINE	Small molecule	0.00165 %	Topical
Comparator	Nystatin	Unknown	500000 iu	Oral

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Summary

Timeline

Publications

Drugs

Indications