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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
This study is currently Recruiting
September 2011 By AIDS Clinical Trials Group
First Recieved on November 3, 2010
Last Updated on September 1, 2011
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.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Arm A: Topical GV solution:Experimental|
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
|Arm B: Nystatin oral suspension:Active Comparator|
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|Drug:Nystatin oral suspension|
Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
confirmed by licensed Western blot or a second antibody test by a method other than
the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- Pseudomembranous candidiasis documented by a complete oral exam (i.e., white or
yellow spots or plaques with an underlying erythematous base that may be located in
any part of the oral cavity) at the screening visit. Participants with documented
angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis
are not eligible to enroll in the study.
- If currently being treated with an ART regimen, initiation of regimen at least 12
weeks prior to study entry, and willingness of participant to remain on current ART
regimen until the study-defined 14-day treatment period is complete. NOTE:
Participants who are not ART-na?ve and not on ART are eligible to participate in the
study if they do not intend to initiate ART during the study- defined 14-day
- CD4+ cell count obtained within 30 days prior to study entry at a DAIDS-approved
- Documented or presumptive signs or symptoms of esophageal candidiasis (e.g.,
dysphagia) during the screening period unless endoscopic examination of the esophagus
was performed and fungal esophagitis was excluded.
- Use of any investigational drug currently or within 30 days prior to study entry.
NOTE: For purposes of this study, drugs available under an FDA-authorized expanded
access program will NOT be considered investigational.
- Concurrent vaginal candidiasis within 21 days prior to study entry.
- Use of inhaled or systemic corticosteroids within 14 days prior to study entry.
- Use of any antifungal agents within 30 days prior to study entry.
- Anticipate need for systemic or oral/topical antifungal agents for other diagnoses
within the study-defined 14-day treatment period.
- Intend to initiate ART during the screening period, at study entry, or within the
study-defined 14-day treatment period.
- Intend to use any additional oral topical treatments within the study- defined 14-day
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or
- Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.
- Serious illness, in the opinion of the site investigator, requiring systemic
- Hospitalization within 30 days prior to study entry for HIV or HIV-related
- Previous or current history of porphyria.
- Presence of oral warts during the screening period or at the study entry visit before
- Current wearing of full dentures or a maxillary partial denture at study entry.
- Investigator: Robert A Salata, MD - Study Chair - Case CRS
- Investigator: James G Hakim, MD - Principal Investigator - UZ- Parirenyatwa CRS
- Investigator: Tim Hodgson, MD - Principal Investigator - Eastman Dental Hospital
- Investigator: Richard J Jurevic, DDS, PhD - Principal Investigator - Case CRS
- Investigator: Pranab K Mukherjee, PhD, MSc - Principal Investigator - Case CRS
- Investigator: Cissy M Kityo, MBChB, MSc - Principal Investigator - JCRC CRS
- Investigator: Rana Traboulsi, MD - Principal Investigator - Case CRS
- Investigator: Srikanth P Tripathy, MD, MBBS - Principal Investigator - NARI Pune CRS
- Gaborone Prevention/Treatment Trials CRS (12701)
- Molepolole Prevention/Treatment Trials CRS (12702)
- National AIDS Research Institute Pune CRS (11601)
Pune, Maharashtra 411026 India
- BJ Medical College CRS (31441)
Pune, Maharashtra 411001 India
- AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)
Eldoret, 30100 Kenya
- Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501)
Kericho, 20200 Kenya
- College of Med. JHU CRS (30301)
- Durban Adult HIV CRS (11201)
Durban, 4013 SF South Africa
- Joint Clinical Research Centre (JCRC) (12401)
- UZ-Parirenyatwa CRS (30313)