Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01427738
First received: November 3, 2010
Last updated: February 12, 2015
Last verified: February 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: Gentian Violet
Drug: Nystatin oral suspension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.

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

Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.


Participant Flow:   Overall Study
    Arm A: Topical GV Solution   Arm B: Nystatin Oral Suspension
STARTED   110   111 
COMPLETED   91   90 
NOT COMPLETED   19   21 
Death                12                9 
Severe debilitation, unable to continue                0                1 
Subject unable to get to clinic                5                2 
Withdrawal by Subject                0                2 
Subject not willing to adhere to reqs                1                2 
Lost to Follow-up                1                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who enrolled.

Reporting Groups
  Description
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

Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.

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

Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.

Total Total of all reporting groups

Baseline Measures
   Arm A: Topical GV Solution   Arm B: Nystatin Oral Suspension   Total 
Overall Participants Analyzed 
[Units: Participants]
 110   111   221 
Age, Customized 
[Units: Participants]
     
10-19 years   0   1   1 
20-29 years   17   30   47 
30-39 years   54   52   106 
40-49 years   21   17   38 
50-59 years   16   9   25 
Over 60 years   2   2   4 
Gender 
[Units: Participants]
     
Female   62   66   128 
Male   48   45   93 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black Non-Hispanic   97   106   203 
Asian, Pacific Islander   13   5   18 
Antiretroviral Therapy Usage 
[Units: Participants]
     
On ART   27   28   55 
Not on ART   83   83   166 
CD4 Count 
[Units: Participants]
     
0-200 cells/microliter   87   88   175 
> 200 cells/microliter   23   23   46 
HIV RNA Viral Load 
[Units: Log10(copies/ml)]
Mean (Standard Deviation)
 4.89  (1.31)   5.03  (1.21)   4.96  (1.26) 


  Outcome Measures
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1.  Primary:   Number of Participants With Clinical Efficacy   [ Time Frame: After 14 days of treatment ]

2.  Secondary:   Number of Participant With Symptom   [ Time Frame: after 14 days of treatment ]

3.  Secondary:   Quantitative Yeast Colony Counts   [ Time Frame: At weeks 0, 2, 6 ]

4.  Secondary:   Tolerance   [ Time Frame: After 14 days of treatment ]

5.  Secondary:   Number of Participants Who Were Adherent.   [ Time Frame: After 14 days of treatment ]

6.  Secondary:   Self-Assessment of General Health   [ Time Frame: Weeks 0, 6 ]

7.  Secondary:   Number of Participants Who Found GV and Nystatin Acceptable.   [ Time Frame: After 14 days of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com



Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01427738     History of Changes
Obsolete Identifiers: NCT01494129
Other Study ID Numbers: ACTG A5265
1U01AI068636 ( US NIH Grant/Contract Award Number )
Study First Received: November 3, 2010
Results First Received: January 6, 2015
Last Updated: February 12, 2015
Health Authority: United States: Federal Government