Compare the Efficacy and Safety of Gentian Violet to that of Nystatin used in the treatment of fungal infection of the mouth in patients infected HIV-1

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/12/003168
• Date of registration: 03-12-2012
• Prospective Registration: Yes
• Primary sponsor: AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA
• Public title: Compare the Efficacy and Safety of Gentian Violet to that of Nystatin used in the treatment of fungal infection of the mouth in patients infected HIV-1
• Scientific title: A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to That of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings
• Date of first enrolment: 31-12-2012
• Target sample size: 494
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5527
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Dr Srikanth Tripathy
• Affiliation: National AIDS Research Institute

• Name: Dr Srikanth Tripathy
• Affiliation: National AIDS Research Institute

Key inclusion & exclusion 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. More information on this criterion can be found in the protocol.

•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. NOTE: Participants with documented angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis are not eligible to enroll in the study.

•Direct microscopic examination (potassium hydroxide [KOH] or Gram-stained smear) consistent with Candida spp. at screening and evidence of pseudomembranous candidiasis within 21 days prior to study entry

•If currently being treated with an antiretroviral therapy (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

•Laboratory values obtained within 7 days prior to study entry:



1.Absolute neutrophil count (ANC) greater than or equal to 750/mm3

2.Hemoglobin greater than or equal to 7.0 g/dL

3.Platelet count greater than or equal to 50,000/mm3

4.Creatinine less than or equal to 3 times the upper limit of normal (ULN)

5.Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and alkaline phosphatase less than or equal to 5 times the ULN

6.Total bilirubin less than or equal to 2.5 times the ULN

7.Serum glucose less than 200 mg/dL (fasting not required)

•Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test (a sensitivity of at least 50 mIU/mL) performed within 48 hours prior to study entry

•If participating in sexual activity that could lead to pregnancy, female study volunteers must use at least one form of contraceptive while receiving protocol-specified medication(s) and for 1 month after stopping the medications. More information on this criterion can be found in the protocol.

•Karnofsky performance score of greater than or equal to 60 within 21 days prior to study entry

•Able and willing to provide informed consent and to attend all planned study visits


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

•Currently wearing full dentures or a maxillary partial denture at study entry



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- HIV Infections

Intervention(s)

Intervention1: Drug Topical GV
: Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and spit twice a day) for 14 days
Control Intervention1: Drug Nystatin Oral Suspension: Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow four times a day) for 14 days

Primary Outcome(s)

1 Lesion severity and extent (clinical efficacy)

2 Clinical efficacy is defined as cure (absence of lesions) or improvement (a decrease in severity and extent of lesions)

3 Severity is scored using a scoring systemTimepoint: 1 Measured at Day 14

2 after 14 days of treatment

3 from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions).

Secondary Outcome(s)

1 Level of discomfort and pain (symptoms)

2 Symptoms will be assessed using a visual analog scale where the level of discomfort and pain will be recorded and quantified using a scoring system

3 Quantitative yeast colony counts

4 Emergence of fungal resistance

5 Emergence of adverse events

6 Participants self-reported tolerance to assigned study medication (GV or nystatin)

7 Cost of treatment

8 Adherence to assigned study medication (GV or nystatin)

Timepoint: 1 Measured at Week 13

2 from 0 to 3.

3 Measured at Week 13

4 Measured at Week 13

5 at Week 13

6 Measured at Week 13

7 Measured at Week 13

8 Measured at Day 14

Secondary ID(s)

ACTG 5265 ,Version no. 1.0,date 19 March 2010

NCT01494129

Source(s) of Monetary Support

AIDS Clinical Trials Group

Ethics review

Status: Approved
Approval date: 08/08/2012
Contact:

NARI Ethics Committee