Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
Condition: HIV-1 Infection
MeSH terms: Candidiasis
Intervention: Gentian Violet; Nystatin oral suspension
Intervention description: Participants were administered topical Gentian violet solution, orally, twice daily for 14 days.; Participants were administered Nystatin oral suspension 4 times a day for 14 days.
Intervention MeSH terms: Nystatin; Gentian Violet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
             chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
             confirmed by licensed Western blot or a second antibody test by a method other than
             the 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 yellow
             spots or plaques with an underlying erythematous base, located in any part of the oral
             cavity) at the screening visit. Participants with documented angular chelitis and/or
             erythematous candidiasis without pseudomembranous candidiasis were not eligible to
             enroll in the study.

          -  If on an antiretroviral therapy (ART), initiation of regimen at least 12 weeks prior
             to study entry, and willingness of participant to remain on current ART regimen until
             the study-defined 14-day treatment period was complete. NOTE: Participants who were
             not ART-naïve and not on ART were eligible to participate in the study if they did not
             intend 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-approved
             laboratory.

        Exclusion Criteria:

          -  Documented or presumptive signs or symptoms of esophageal candidiasis (e.g.,
             dysphagia) during the screening period unless endoscopic examination of the esophagus
             was 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 expanded
             access 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 diagnoses
             within the study-defined 14-day treatment period.

          -  Intend to initiate ART during the screening period, at study entry, or within the
             study-defined 14-day treatment period.

          -  Intend to use any additional oral topical treatments within the study- defined 14-day
             treatment period.

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulation.

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements.

          -  Serious illness, in the opinion of the site investigator, requiring systemic
             treatment.

          -  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 before
             randomization.

          -  Current wearing of full dentures or a maxillary partial denture at study entry