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

NCT01427738 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2015-02-16

Study results available
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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

Interventions

DRUG

Gentian Violet

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

DRUG

Nystatin oral suspension

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Robert A Salata, MD · Case CRS

  • James G Hakim, MD · UZ- Parirenyatwa CRS

  • Tim Hodgson, MD · Eastman Dental Hospital

  • Richard J Jurevic, DDS, PhD · Case CRS

  • Pranab K Mukherjee, PhD, MSc · Case CRS

  • Cissy M Kityo, MBChB, MSc · JCRC CRS

  • Rana Traboulsi, MD · Case CRS

  • Srikanth P Tripathy, MD, MBBS · NARI Pune CRS

  • Mahmoud A Ghannoum, Phd, MSc · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-09-30
Completion
2014-01-31

Countries

  • Botswana
  • India
  • Kenya
  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427738 on ClinicalTrials.gov