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

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

Sponsors

Lead Sponsor: AIDS Clinical Trials Group

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Source AIDS Clinical Trials Group
Brief Summary

The purpose of this study was to see which one of two medicines (topical gentian violet [GV] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had 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 were assessed.

Detailed Description

A5265 was a phase III, open-label (both the researchers and participants know which treatment was 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 were 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 was 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 was done by an evaluator who was blinded to the treatment assignment. A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled; and participants are expected to be on the study for about 13 weeks.

Overall Status Completed
Start Date June 2011
Completion Date January 2014
Primary Completion Date September 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Clinical Efficacy After 14 days of treatment
Secondary Outcome
Measure Time Frame
Number of Participant With Symptom after 14 days of treatment
Quantitative Yeast Colony Counts At weeks 0, 2, 6
Tolerance After 14 days of treatment
Number of Participants Who Were Adherent. After 14 days of treatment
Self-Assessment of General Health Weeks 0, 6
Number of Participants Who Found GV and Nystatin Acceptable. After 14 days of treatment
Enrollment 221
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gentian Violet

Description: Participants were administered topical Gentian violet solution, orally, twice daily for 14 days.

Arm Group Label: Arm A: Topical GV solution

Intervention Type: Drug

Intervention Name: Nystatin oral suspension

Description: Participants were administered Nystatin oral suspension 4 times a day for 14 days.

Arm Group Label: Arm B: Nystatin oral suspension

Eligibility

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, located in any part of the oral cavity) at the screening visit. Participants with documented angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis were not eligible to enroll in the study. - If on an antiretroviral therapy (ART), 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 was complete. NOTE: Participants who were not ART-naïve and not on ART were eligible to participate in the study if they did 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 were 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 was NOT 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. - Anticipated 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility:
Gaborone Prevention/Treatment Trials CRS (12701) | Gaborone, Botswana
Molepolole Prevention/Treatment Trials CRS (12702) | Molepolole, Botswana
BJ Medical College CRS (31441) | Pune, Maharashtra, 411001, India
National AIDS Research Institute Pune CRS (11601) | Pune, Maharashtra, 411026, 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) | Blantyre, Malawi
Durban Adult HIV CRS (11201) | Durban, 4013 SF, South Africa
Joint Clinical Research Centre (JCRC) (12401) | Kampala, Uganda
UZ-Parirenyatwa CRS (30313) | Harare, Zimbabwe
Location Countries

Botswana

India

Kenya

Malawi

South Africa

Uganda

Zimbabwe

Verification Date

February 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm A: Topical GV solution

Type: Experimental

Description: Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days

Label: Arm B: Nystatin oral suspension

Type: Active Comparator

Description: Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov