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CompletedNCT00002394Updated Jun 24, 2005

Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

An interventional study of Terbinafine hydrochloride in Candidiasis, Oral and HIV Infections, sponsored by Novartis. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Novartis · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to see if it is safe and effective to give Lamisil to HIV-positive patients with thrush (a fungal infection) that has not responded to fluconazole.

Read the detailed description

This is an open-label, dose-escalating study with up to 2 sequential cohorts. The first 15 patients receive Lamisil for 2 weeks. After 2 weeks, patients considered clinically cured (i.e., absence of removable, white plaques) are removed from treatment; patients not considered clinically cured receive an additional 2 weeks of treatment. At the end of 4 weeks, treatment is discontinued, regardless of clinical cure outcome. If less than 80% of patients are clinically cured after the 4 weeks of treatment, a second cohort of 15 patients receive Lamisil on the same treatment regimen as first cohort (i.e., initial 2-week treatment period, with an additional 2 weeks of treatment for those patients who are not considered clinically cured after 2 weeks of treatment).

02

Conditions studied

  • Candidiasis, Oral
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Dose-Response Relationship, Drug
  • Fluconazole
  • Antifungal Agents
  • Candidiasis, Oral
  • Drug Administration Schedule
  • terbinafine
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 30 is below the median of 99 across 186 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

You may be eligible for this study if you:

  • Are at least 18 years old.
  • Have thrush that has not responded to at least 10 days of fluconazole treatment.
  • Are HIV-positive.
  • Are expected to live at least 4 weeks.
  • Are able to take oral medication.

Exclusion criteria

Exclusion Criteria

You will not be eligible for this study if you:

  • Have liver or kidney disease.
  • Have received certain medications.
  • Have a history of serious diarrhea or digestive problems.
  • Are pregnant or breast-feeding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
30 participants

Interventions

  • DrugTerbinafine hydrochloride
06

Study locations

9 sites
  • Therafirst Med Ctr
    Fort Lauderdale, Florida 33308, United States
  • Associates in Research
    Fort Myers, Florida 33901, United States
  • Clireco Inc
    Tamarac, Florida 33321, United States
  • Infectious Diseases Research Inc
    Tampa, Florida 33614, United States
  • Northwestern Univ / Division of Infectious Disease
    Chicago, Illinois 60611, United States
  • Saint Michaels Med Ctr / Infectious Disease Resch Dpt
    Newark, New Jersey 071029880, United States
  • St Vincents Hosp / Clinical Research Program
    New York, New York 10011, United States
  • Univ of Texas Med Branch
    Galveston, Texas 77555, United States
  • Hampton Roads Med Specialists
    Hampton, Virginia 23666, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002394
Lead sponsor
Novartis
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 1999. You cannot join it, but the record below documents what was studied.

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