Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

NCT02184351 | Completed Phase 3

• 1 other identifier: 1190.1
• Study Type: interventional
• Target: 187
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.

Conditions

Candidiasis, Oral

Outcome Measures

Primary Outcomes (1)

• Percent of patients that have a clinical response assessed by symptoms and physical examination

  Day 21

Secondary Outcomes (4)

• Incidence of negative fungal cultures of the oropharynx for Candida species

  7 days after end of treatment

• Incidence of negative fungal cultures of the oropharynx for Candida species

  after 14 days of treatment

• Clinical response by symptom assessment and physical examination

  after 7 and 14 days of treatment

• Assessment of compliance with Treatment by troche Count and Patient interview

  after 7 and 14 days of treatment

Study Arms (2)

Roxanes's clotrimazole troches

EXPERIMENTAL

Drug: Roxanes's clotrimazole troches

Mycelex® troches

ACTIVE COMPARATOR

Drug: Mycelex® troches

Interventions

Roxanes's clotrimazole troches DRUG

Roxanes's clotrimazole troches

Mycelex® troches DRUG

Mycelex® troches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV positive status
• Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
• Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
• Male or female patients ≥ 18 years
• For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
• Mental status allows comprehension of instructions for troche administration
• Written informed consent

You may not qualify if:

• Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
• Presence of perioral lesions only
• Use of other antifungal agents within 5 days of enrollment to the study
• Pregnant or lactating women
• History of hypersensitivity to imidazole or azole compounds
• Patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks)
• Patients has received an investigational drug in the last 30 days
• Treatment with another investigational drug is planned within the next 3 weeks

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Candidiasis, Oral

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: May 1, 2001
• Primary Completion: November 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07