Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
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.
Drug: Gentian Violet
Drug: Nystatin oral suspension
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Gentian Violet Oral Solution to That of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings|
- Number of Participants With Clinical Efficacy [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.
- Number of Participant With Symptom [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.
- Quantitative Yeast Colony Counts [ Time Frame: At weeks 0, 2, 6 ] [ Designated as safety issue: No ]If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success
- Tolerance [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)
- Number of Participants Who Were Adherent. [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28*0.15=4 doses; and for the nystatin arm is 56*0.15=8 doses.
- Self-Assessment of General Health [ Time Frame: Weeks 0, 6 ] [ Designated as safety issue: No ]Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)
- Number of Participants Who Found GV and Nystatin Acceptable. [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.
|Study Start Date:||June 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm A: Topical GV solution
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Drug: Gentian Violet
Participants were administered topical Gentian violet solution, orally, twice daily for 14 days.
Active Comparator: Arm B: Nystatin oral suspension
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Drug: Nystatin oral suspension
Participants were administered Nystatin oral suspension 4 times a day for 14 days.
A5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled; and participants are expected to be on the study for about 13 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427738
|Gaborone Prevention/Treatment Trials CRS (12701)|
|Molepolole Prevention/Treatment Trials CRS (12702)|
|National AIDS Research Institute Pune CRS (11601)|
|Pune, Maharashtra, India, 411026|
|BJ Medical College CRS (31441)|
|Pune, Maharashtra, India, 411001|
|AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)|
|Eldoret, Kenya, 30100|
|Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501)|
|Kericho, Kenya, 20200|
|College of Med. JHU CRS (30301)|
|Durban Adult HIV CRS (11201)|
|Durban, South Africa, 4013 SF|
|Joint Clinical Research Centre (JCRC) (12401)|
|UZ-Parirenyatwa CRS (30313)|
|Study Chair:||Robert A Salata, MD||Case CRS|
|Principal Investigator:||James G Hakim, MD||UZ- Parirenyatwa CRS|
|Principal Investigator:||Tim Hodgson, MD||Eastman Dental Hospital|
|Principal Investigator:||Richard J Jurevic, DDS, PhD||Case CRS|
|Principal Investigator:||Pranab K Mukherjee, PhD, MSc||Case CRS|
|Principal Investigator:||Cissy M Kityo, MBChB, MSc||JCRC CRS|
|Principal Investigator:||Rana Traboulsi, MD||Case CRS|
|Principal Investigator:||Srikanth P Tripathy, MD, MBBS||NARI Pune CRS|
|Principal Investigator:||Mahmoud A Ghannoum, Phd, MSc||Case Western Reserve University|