Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
The purpose of this study is to see which one of two medicines (topical gentian violet [GV] or nystatin oral suspension) is better than the other in treating Oral Candidiasis (OC). This will be measured by whether the study participant still has 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 will be 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|
- Clinical efficacy [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]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.
- Symptom [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]Symptoms will be assessed using a visual analog scale where the level of discomfort and pain will be recorded and quantified using a scoring system from 0 to 3
- Quantitative yeast colony counts [ Time Frame: at week 2, 6, or 13 visits ] [ Designated as safety issue: No ]If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success
- Emergence of fungal resistance [ Time Frame: If there is reappearance of signs or symptoms of OC between weeks 2 and 8 ] [ Designated as safety issue: No ]To determine if GV and nystatin have the potential for the development of resistance
- Emergence of adverse events [ Time Frame: during the 14 day treatment period ] [ Designated as safety issue: Yes ]Safety will be evaluated by summarizing the nature and rate of adverse events within each arm
- Cost of treatment [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]Assessment of the cost and efficacy of the treatment options will aid policy makers in resource-limited settings in choosing the most cost-effective strategies
- 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.)
- Adherence [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]Adherence will be reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adequate adherence, 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 [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]Participants will rate 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) and is a rating scale from 0 (defined as "death or worse possible health") to 100 (defined as "perfect or best possible health").
- Acceptability of GV and nystatin [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]Acceptability will be defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants will be asked whether or not they are willing to use the assigned treatment via questionnaires.
|Study Start Date:||June 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (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 will be 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 will be administered Nystatin oral suspension 4 times a day for 14 days.
A5265 is a phase III, open-label (both the researchers and participants know which treatment is 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 will be 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 will be 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 will be done by an evaluator who is blinded to the treatment assignment. A total of 494 participants will enroll in the study, 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)|
|BJ Medical College CRS (31441)|
|Pune, Maharashtra, India, 411001|
|National AIDS Research Institute Pune CRS (11601)|
|Pune, Maharashtra, India, 411026|
|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|