CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 221 enrolled
Drug / intervention
Gentian Violet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01427738
NCT01427738Phase 3Completed
CompareCT.gov

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

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Sep 2, 2011·Updated Feb 16, 2015

In Brief

A Phase 3 clinical trial evaluating Gentian Violet and Nystatin oral suspension for HIV-1 Infection. Completed, enrolled 221 participants across 10 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBotswana, India, Kenya, Malawi, South Africa, Uganda, Zimbabwe
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2012
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

Gentian Violetdrug

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

Nystatin oral suspensiondrug

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