Skip to main content
OpenTrials
Completed

NCT Number: NCT02184351

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candidiasis, Oral Bacterial Infections and Mycoses Candidiasis Infections Mouth Diseases Mycoses Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Roxanes's clotrimazole troches

Drug

Mycelex® troches

Drug

Primary outcomes

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

    Time frame: Day 21

Secondary outcomes

  1. Incidence of negative fungal cultures of the oropharynx for Candida species

    Time frame: 7 days after end of treatment

  2. Incidence of negative fungal cultures of the oropharynx for Candida species

    Time frame: after 14 days of treatment

  3. Clinical response by symptom assessment and physical examination

    Time frame: after 7 and 14 days of treatment

  4. Assessment of compliance with Treatment by troche Count and Patient interview

    Time frame: after 7 and 14 days of treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

Important dates

Study start
2001
Primary completion
2001
First posted
Jul 9, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.