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

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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


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
Results First Received: January 6, 2015
Last Updated: February 12, 2015
Health Authority: United States: Federal Government