Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
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|ClinicalTrials.gov Identifier: NCT01427738|
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: Gentian Violet Drug: Nystatin oral suspension||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||January 2014|
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.
- Number of Participants With Clinical Efficacy [ Time Frame: After 14 days of treatment ]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 ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Mahmoud A Ghannoum, Phd, MSc||Case Western Reserve University|