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

NCT ID: NCT01427738

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-01-31

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.

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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Topical GV solution

Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days

Group Type: EXPERIMENTAL

Gentian Violet

Intervention Type: DRUG

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

Arm B: Nystatin oral suspension

Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days

Group Type: ACTIVE_COMPARATOR

Nystatin oral suspension

Intervention Type: DRUG

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

Interventions

Gentian Violet

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

Intervention Type: DRUG

Nystatin oral suspension

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert A Salata, MD

Role: STUDY_CHAIR

Case CRS

James G Hakim, MD

Role: PRINCIPAL_INVESTIGATOR

UZ- Parirenyatwa CRS

Tim Hodgson, MD

Role: PRINCIPAL_INVESTIGATOR

Eastman Dental Hospital

Richard J Jurevic, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Case CRS

Pranab K Mukherjee, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Case CRS

Cissy M Kityo, MBChB, MSc

Role: PRINCIPAL_INVESTIGATOR

JCRC CRS

Rana Traboulsi, MD

Role: PRINCIPAL_INVESTIGATOR

Case CRS

Srikanth P Tripathy, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

NARI Pune CRS

Mahmoud A Ghannoum, Phd, MSc

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Gaborone Prevention/Treatment Trials CRS (12701)

Gaborone, , Botswana

Molepolole Prevention/Treatment Trials CRS (12702)

Molepolole, , Botswana

BJ Medical College CRS (31441)

Pune, Maharashtra, India

National AIDS Research Institute Pune CRS (11601)

Pune, Maharashtra, India

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

Eldoret, , Kenya

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

Kericho, , Kenya

College of Med. JHU CRS (30301)

Blantyre, , Malawi

Durban Adult HIV CRS (11201)

Durban, , South Africa

Joint Clinical Research Centre (JCRC) (12401)

Kampala, , Uganda

UZ-Parirenyatwa CRS (30313)

Harare, , Zimbabwe

Countries

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

References

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.

Reference Type: DERIVED

PMID: 27677161 (View on PubMed)

Other Identifiers

1U01AI068636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACTG A5265

Identifier Type: -

Identifier Source: org_study_id

NCT01494129

Identifier Type: -

Identifier Source: nct_alias