Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by AIDS Clinical Trials Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01427738
First received: November 3, 2010
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: Gentian Violet
Drug: Nystatin oral suspension
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 494
Study Start Date: June 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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-naïve 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 treatment period.
  • CD4+ cell count obtained within 30 days prior to study entry at a DAIDS-approved laboratory.

Exclusion Criteria:

  • 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 treatment period.
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
  • 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 treatment.
  • Hospitalization within 30 days prior to study entry for HIV or HIV-related conditions.
  • Previous or current history of porphyria.
  • Presence of oral warts during the screening period or at the study entry visit before randomization.
  • Current wearing of full dentures or a maxillary partial denture at study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427738

Locations
Botswana
Gaborone Prevention/Treatment Trials CRS (12701) Recruiting
Gaborone, Botswana
Contact: Tebogo Kakhu    (011 267) 393-1146    tkakhu@bhp.org.bw   
Principal Investigator: Anthony Ogwu, MBBS         
Molepolole Prevention/Treatment Trials CRS (12702) Recruiting
Molepolole, Botswana
Contact: Evans Moko, MB, ChB, MPH    011-267-592-1013    emoko@bhp.org.bw   
Principal Investigator: Aida Asmelash, MD, MPH         
India
National AIDS Research Institute Pune CRS (11601) Not yet recruiting
Pune, Maharashtra, India, 411026
Contact: Sampada Dhayarkar, MBBS    91-20-27121280    sdhayarkar@gmail.com   
Principal Investigator: Srikanth P. Tripathy, MD, MBBS         
BJ Medical College CRS (31441) Not yet recruiting
Pune, Maharashtra, India, 411001
Contact: Nishi Suryavanshi, PhD    011912026052419    nishisuryavanshi@hotmail.com   
Principal Investigator: Vidya Mave, MD, TM, MPH         
Kenya
AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601) Not yet recruiting
Eldoret, Kenya, 30100
Contact: Priscilla C. Cheruiyot    254-53-2060850    pcchepkorir@yahoo.com   
Principal Investigator: Abraham M. Siika, MMED         
Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501) Not yet recruiting
Kericho, Kenya, 20200
Contact: Hellen Ngeno    254-5230388    hngeno@wrp-kch.org   
Principal Investigator: Fredrick Sawe, MB, ChB, MMED         
Malawi
College of Med. JHU CRS (30301) Recruiting
Blantyre, Malawi
Contact: Leslie H. Degnan, M.P.H.    265-888-208609    ldegnan@jhu.medcol.mw   
Principal Investigator: Newton Kumwenda, MPH, PhD         
South Africa
Durban Adult HIV CRS (11201) Recruiting
Durban, South Africa, 4013 SF
Contact: Fawzia Williamson    27 31 260 4365    amodf1@nu.ac.za   
Principal Investigator: Umesh Gangaram Lalloo, MD, FRCP         
Uganda
Joint Clinical Research Centre (JCRC) (12401) Not yet recruiting
Kampala, Uganda
Contact: Sandra Rwambuya    (256) 413-42521    dxr23@case.edu   
Principal Investigator: Peter Mugyenyi, MB ChB, FRCP, DSc         
Zimbabwe
UZ-Parirenyatwa CRS (30313) Not yet recruiting
Harare, Zimbabwe
Contact: Jimijika Batani, B.A.    263-912272818    jbatani@uz-ucsf.co.zw   
Principal Investigator: James Hakim, MD, MSc, FRCP         
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
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
  More Information

No publications provided

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01427738     History of Changes
Obsolete Identifiers: NCT01494129
Other Study ID Numbers: ACTG A5265, 1U01AI068636
Study First Received: November 3, 2010
Last Updated: September 1, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Candidiasis
HIV Infections
Mycoses
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Gentian Violet
Nystatin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014