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

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

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

Phase: Phase 3

Status: Completed

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
Mahmoud A Ghannoum, Phd, MSc, Principal Investigator, Affiliation: Case Western Reserve University

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.

Clinical Details

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: Number of Participants With Clinical Efficacy

Secondary outcome:

Number of Participant With Symptom

Quantitative Yeast Colony Counts

Tolerance

Number of Participants Who Were Adherent.

Self-Assessment of General Health

Number of Participants Who Found GV and Nystatin Acceptable.

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.

Eligibility

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, 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

Locations and Contacts

Gaborone Prevention/Treatment Trials CRS (12701), Gaborone, Botswana

Molepolole Prevention/Treatment Trials CRS (12702), Molepolole, Botswana

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

BJ Medical College CRS (31441), Pune, Maharashtra 411001, India

National AIDS Research Institute Pune CRS (11601), Pune, Maharashtra 411026, India

Additional Information

Starting date: June 2011
Last updated: February 12, 2015

Page last updated: August 23, 2015

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