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

Inclusion Criteria:

• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme orchemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry andconfirmed by licensed Western blot or a second antibody test by a method other thanthe initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

• Pseudomembranous candidiasis documented by a complete oral exam (i.e., white or yellowspots or plaques with an underlying erythematous base, located in any part of the oralcavity) at the screening visit. Participants with documented angular chelitis and/orerythematous candidiasis without pseudomembranous candidiasis were not eligible toenroll in the study.

• If on an antiretroviral therapy (ART), initiation of regimen at least 12 weeks priorto study entry, and willingness of participant to remain on current ART regimen untilthe study-defined 14-day treatment period was complete. NOTE: Participants who werenot ART-naïve and not on ART were eligible to participate in the study if they did notintend to initiate ART during the study- defined 14-day treatment period.

• CD4+ cell count obtained within 30 days prior to study entry at a DAIDS-approvedlaboratory.

Exclusion Criteria:

• Documented or presumptive signs or symptoms of esophageal candidiasis (e.g.,dysphagia) during the screening period unless endoscopic examination of the esophaguswas performed, and fungal esophagitis were excluded.

• Use of any investigational drug currently or within 30 days prior to study entry.NOTE: For purposes of this study, drugs available under an FDA-authorized expandedaccess program was NOT considered investigational.

• Concurrent vaginal candidiasis within 21 days prior to study entry.

• Use of inhaled or systemic corticosteroids within 14 days prior to study entry.

• Use of any antifungal agents within 30 days prior to study entry.

• Anticipated need for systemic or oral/topical antifungal agents for other diagnoseswithin the study-defined 14-day treatment period.

• Intend to initiate ART during the screening period, at study entry, or within thestudy-defined 14-day treatment period.

• Intend to use any additional oral topical treatments within the study- defined 14-daytreatment period.

• Known allergy/sensitivity or any hypersensitivity to components of study drugs ortheir formulation.

• Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements.

• Serious illness, in the opinion of the site investigator, requiring systemictreatment.

• Hospitalization within 30 days prior to study entry for HIV or HIV-related conditions.

• Previous or current history of porphyria.

• Presence of oral warts during the screening period or at the study entry visit beforerandomization.

• Current wearing of full dentures or a maxillary partial denture at study entry