Completed
Itraconazole Oral Solution for Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Individuals
What is being tested
Itraconazole
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorJanssen, LP
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.
Principal SponsorJanssen, LP
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.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.From 18 to 65 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 DiseasesMycosesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexCandidiasis, OralHIV Infections
Criteria
6 inclusion criteria required to participate
Confirmed oropharyngeal candidiasis
Failed fluconazole treatment within the past 14 days
HIV antibody seropositivity or diagnosis of AIDS
Life expectancy of at least 3 months
Show More Criteria
13 exclusion criteria prevent from participating
Astemizole
Carbamazepine
Clinical evidence of significant hepatic disease within the past 2 months
Considered unreliable about following physician's directives
Show More Criteria
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 18 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsUniv of Arkansas for Med Sciences
Little Rock, United StatesEast Bay AIDS Ctr
Berkeley, United StatesKaiser Permanente Med Ctr
San Francisco, United StatesCompleted18 Study Centers