In the present study, we compared the safety and efficacy of topical GV to that of NYS in the treatment of OC in HIV-infected adult participants from RLS. In an earlier study, our group reported that oral rinsing with GV at low concentrations (0.00165%, 16.5 μg/mL) was safe and well-tolerated, with no mucosal staining. GV has been recommended by the World Health Organization (WHO) as a topical treatment for OC in HIV-infected participants, at a concentration of 1%. To identify a low cost alternative to current treatment, our group conducted preclinical studies and found GV possesses potent anti- Candida activity. Nystatin oral suspension (NYS) is the main antifungal used to treat OC in HIV-infected participants in RLS. Although the incidence of OC has declined in resource-rich countries following the introduction of highly active antiretroviral therapy (HAART), the prevalence of OC in HIV-infected participants in resource-limited settings (RLS) remains substantial, reaching as high as 33%. Recent studies conducted by the Oral HIV AIDS Research Alliance (OHARA) of the AIDS Clinical Trials Group (ACTG) demonstrated that OC is strongly associated with tuberculosis in HIV-infected participants, independent of CD4 count. Left untreated, OC can contribute to morbidity including esophageal disease and weight loss. Oral candidiasis (OC) is among the most common opportunistic infections observed in HIV-infected individuals and often presents as the initial manifestation of disease. dollars) for nystatin (NYS) and gentian violet (GV). Supplementary Table 1: Quantitative fungal counts in gentian violet (GV) and nystatin (NYS) arms, evaluated in swabs collected at different time points during the study Cost per treatment course of nystatin or gentian violet.Ĭost of treatment with nystatin or gentian violet were compared using non-parametric test (Mann Whitney, two-tailed) and a P-value <. Both the oral examiner and clinical staff were asked to use this diagram during the oral exam and oral treatment interview, respectively. ![]() Participating sites were encouraged to use the oral cavity diagram to assess ulcerations and staining. ![]() (1) Left lower and upper labial mucosa and buccal mucosa, (2) right lower and upper labial mucosa and buccal mucosa, (3) hard palate, (4) soft palate, (5) tongue (dorsum, lateral, and ventral), (6) floor of mouth. ![]() Supplemental Data File _.doc_.tif_ pdf_etc._1: Supplementary Figure 1.
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