Completed

Assessment of Lamisil's Safety and Efficacy in HIV-Positive Patients With Oral Mucosal Candidiasis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and effectiveness of Lamisil in treating oral mucosal candidiasis in individuals who are HIV-positive.

What is being tested

Terbinafine hydrochloride

Drug
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNovartis
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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).

NCT00002394
Principal SponsorNovartis
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCandidiasisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCandidiasis, OralHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Have thrush that has not responded to at least 10 days of fluconazole treatment.

Are at least 18 years old.

Are HIV-positive.

Are able to take oral medication.

Show More Criteria

4 exclusion criteria prevent from participating
Have a history of serious diarrhea or digestive problems.

Have liver or kidney disease.

Are pregnant or breast-feeding.

Have received certain medications.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Therafirst Med Ctr

Fort Lauderdale, United StatesOpen Therafirst Med Ctr in Google Maps

Associates in Research

Fort Myers, United States

Clireco Inc

Tamarac, United States

Infectious Diseases Research Inc

Tampa, United States
Completed9 Study Centers