Completed
Maintenance Therapy with Itraconazole Oral Solution for HIV-Positive Patients with Fluconazole-Refractory Oropharyngeal Candidiasis
What is being tested
Itraconazole
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+16 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 who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
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
2 inclusion criteria required to participate
Life expectancy of at least 3 months.
Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
14 exclusion criteria prevent from participating
Rifampin.
Phenytoin.
Astemizole.
Rifabutin.
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 1 location
Buckley Braffman Stern Med Associates
Philadelphia, United StatesOpen Buckley Braffman Stern Med Associates in Google MapsCompletedOne Study Center