| Protocol No: | ECCT/11/02/01 | Date of Protocol: | 19-03-2010 |
| Study Title: | A5265 - 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 Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings |
| Study Objectives: | 1.2 Primary Objective
To evaluate the clinical efficacy of topical GV solution compared to nystatin oral suspension in the treatment of OC, as evidenced by pseudomembranous candidiasis, in HIV-infected adult participants. 1.3 Secondary Objectives
1.3.1 To evaluate symptoms associated with OC at entry, end of treatment, and at clinical relapse.
1.3.2 To evaluate quantitative yeast colony counts at entry, end of treatment, week 6, and at clinical relapse.
1.3.3 To evaluate the effect of strata (baseline CD4+ T-cell count and ART) on clinical efficacy.
1.3.4 To assess the emergence, if any, of fungal resistance in the treatment arms.
1.3.5 To evaluate the safety of GV and nystatin in the treatment of OC.
1.3.6 To evaluate participant tolerance, adherence, self-reported quality of life, and acceptability of GV and nystatin.
1.3.7 To perform a cost analysis comparing the strategies of no treatment, treatment with nystatin, and treatment with GV for OC based on clinical efficacy as established by the trial and country-specific cost data.
1.3.8 To create a specimen repository of oral rinse, serum, plasma, and Candida isolates that can be a resource for other AIDS Clinical Trials Group (ACTG) and Oral HIV/AIDS Research Alliance (OHARA) investigators. |
| Laymans Summary: | The purpose of the study is to evaluate the clinical efficacy of topical Gentian Violet (GV) solution compared to nystatin oral suspension in the treatment of Oral Candindiasis (OC), as evidenced by pseudomembranous candidiasis, in HIV-infected adult participants.
Oral candidiasis is among the most common opportunistic infections observed in HIV- infected individuals. OC tends to occur in about 60% of patients with a CD4+ T-cell count of < 100-200 cells/mm3. Of these, more than half experience a recurrence diagnosis.
Oral candidiasis is still prevalent in the era of HAART therapy. In addition, OC is still the most prevalent oral complication in HIV-infected persons in resource-limited settings, with a reported prevalence rate ranging between 38-54% in Sub-Saharan Africa
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. |
| Abstract of Study: | DESIGN 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. Adherence will be assessed through participant self-report aided by medication diaries and adherence assessment. In addition, study medication bottles will be collected by site staff. Participants will be asked to complete a resource utilization form to quantify the number of clinic visits and hospital days incurred.
DURATION Participants will be on study for 13 weeks.
SAMPLE SIZE A total of 494 participants will enroll in the study.
POPULATION HIV-1 positive men and women ≥ 18 years of age with OC.
STRATIFICATION Participants will be stratified according to the following criteria:
REGIMEN Participants will be randomized with equal proportion to receive one of the two study treatments:
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