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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02184351
First received: July 8, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Candidiasis, Oral
Drug: Roxanes's clotrimazole troches
Drug: Mycelex® troches
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percent of patients that have a clinical response assessed by symptoms and physical examination [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: 7 days after end of treatment ] [ Designated as safety issue: No ]
  • Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]
  • Clinical response by symptom assessment and physical examination [ Time Frame: after 7 and 14 days of treatment ] [ Designated as safety issue: No ]
  • Assessment of compliance with Treatment by troche Count and Patient interview [ Time Frame: after 7 and 14 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: May 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roxanes's clotrimazole troches Drug: Roxanes's clotrimazole troches
Active Comparator: Mycelex® troches Drug: Mycelex® troches

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02184351     History of Changes
Other Study ID Numbers: 1190.1
Study First Received: July 8, 2014
Last Updated: July 11, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases
Miconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014