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

Condition(s) targeted: HIV-1 Infection

Intervention: Gentian Violet (Drug); Nystatin oral suspension (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Robert A Salata, MD, Study Chair, Affiliation: Case CRS
James G Hakim, MD, Principal Investigator, Affiliation: UZ- Parirenyatwa CRS
Tim Hodgson, MD, Principal Investigator, Affiliation: Eastman Dental Hospital
Richard J Jurevic, DDS, PhD, Principal Investigator, Affiliation: Case CRS
Pranab K Mukherjee, PhD, MSc, Principal Investigator, Affiliation: Case CRS
Cissy M Kityo, MBChB, MSc, Principal Investigator, Affiliation: JCRC CRS
Rana Traboulsi, MD, Principal Investigator, Affiliation: Case CRS
Srikanth P Tripathy, MD, MBBS, Principal Investigator, Affiliation: NARI Pune CRS

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical efficacy

Secondary outcome:

Symptom

Quantitative yeast colony counts

Emergence of fungal resistance

Emergence of adverse events

Cost of treatment

Tolerance

Adherence

Self-Assessment

Acceptability of GV and nystatin

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Gaborone Prevention/Treatment Trials CRS (12701), Gaborone, Botswana; Recruiting
Tebogo Kakhu, Phone: (011 267) 393-1146, Email: tkakhu@bhp.org.bw
Anthony Ogwu, MBBS, Principal Investigator

Molepolole Prevention/Treatment Trials CRS (12702), Molepolole, Botswana; Recruiting
Evans Moko, MB, ChB, MPH, Phone: 011-267-592-1013, Email: emoko@bhp.org.bw
Aida Asmelash, MD, MPH, Principal Investigator

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret 30100, Kenya; Not yet recruiting
Priscilla C. Cheruiyot, Phone: 254-53-2060850, Email: pcchepkorir@yahoo.com
Abraham M. Siika, MMED, Principal Investigator

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501), Kericho 20200, Kenya; Not yet recruiting
Hellen Ngeno, Phone: 254-5230388, Email: hngeno@wrp-kch.org
Fredrick Sawe, MB, ChB, MMED, Principal Investigator

College of Med. JHU CRS (30301), Blantyre, Malawi; Recruiting
Leslie H. Degnan, M.P.H., Phone: 265-888-208609, Email: ldegnan@jhu.medcol.mw
Newton Kumwenda, MPH, PhD, Principal Investigator

Durban Adult HIV CRS (11201), Durban 4013 SF, South Africa; Recruiting
Fawzia Williamson, Phone: 27 31 260 4365, Email: amodf1@nu.ac.za
Umesh Gangaram Lalloo, MD, FRCP, Principal Investigator

Joint Clinical Research Centre (JCRC) (12401), Kampala, Uganda; Not yet recruiting
Sandra Rwambuya, Phone: (256) 413-42521, Email: dxr23@case.edu
Peter Mugyenyi, MB ChB, FRCP, DSc, Principal Investigator

UZ-Parirenyatwa CRS (30313), Harare, Zimbabwe; Not yet recruiting
Jimijika Batani, B.A., Phone: 263-912272818, Email: jbatani@uz-ucsf.co.zw
James Hakim, MD, MSc, FRCP, Principal Investigator

National AIDS Research Institute Pune CRS (11601), Pune, Maharashtra 411026, India; Not yet recruiting
Sampada Dhayarkar, MBBS, Phone: 91-20-27121280, Email: sdhayarkar@gmail.com
Srikanth P. Tripathy, MD, MBBS, Principal Investigator

BJ Medical College CRS (31441), Pune, Maharashtra 411001, India; Not yet recruiting
Nishi Suryavanshi, PhD, Phone: 011912026052419, Email: nishisuryavanshi@hotmail.com
Vidya Mave, MD, TM, MPH, Principal Investigator

Starting date: June 2011
Last updated: September 1, 2011