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

NCT01427738 | Completed Phase 3 Results DMC

• 2 other identifiers: ACTG A52651U01AI068636
• Study Type: interventional
• Target: 221
• Locations: 7 countries
• Sites: 10

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Efficacy

  The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.

  After 14 days of treatment

Secondary Outcomes (6)

• 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

Study Arms (2)

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

Drug: Gentian Violet

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

Drug: Nystatin oral suspension

Interventions

Gentian Violet DRUG

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

Arm A: Topical GV solution

Nystatin oral suspension DRUG

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

Arm B: Nystatin oral suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (10)

Gaborone Prevention/Treatment Trials CRS (12701)

Gaborone, Botswana

Location

Molepolole Prevention/Treatment Trials CRS (12702)

Molepolole, Botswana

Location

BJ Medical College CRS (31441)

Pune, Maharashtra, 411001, India

Location

National AIDS Research Institute Pune CRS (11601)

Pune, Maharashtra, 411026, India

Location

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)

Eldoret, 30100, Kenya

Location

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501)

Kericho, 20200, Kenya

Location

College of Med. JHU CRS (30301)

Blantyre, Malawi

Location

Durban Adult HIV CRS (11201)

Durban, 4013 SF, South Africa

Location

Joint Clinical Research Centre (JCRC) (12401)

Kampala, Uganda

Location

UZ-Parirenyatwa CRS (30313)

Harare, Zimbabwe

Location

Related Publications (1)

• Mukherjee PK, Chen H, Patton LL, Evans S, Lee A, Kumwenda J, Hakim J, Masheto G, Sawe F, Pho MT, Freedberg KA, Shiboski CH, Ghannoum MA, Salata RA; Oral HIVAIDS Research Alliance (OHARA)AIDS Clinical Trials Group (ACTG) 5265 Team. Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. AIDS. 2017 Jan 2;31(1):81-88. doi: 10.1097/QAD.0000000000001286.

  PMID: 27677161 DERIVED

MeSH Terms

Interventions

Gentian Violet

Intervention Hierarchy (Ancestors)

Aniline Compounds; Amines; Organic Chemicals

Results Point of Contact

• Title: ACTG Clinicaltrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• Robert A Salata, MD

  Case CRS

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Mahmoud A Ghannoum, Phd, MSc

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: September 2, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2014
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2015-02

Locations

IN (2); BO (2); MA (1); ZA (1); ZI (1); UG (1); KE (2)