Completed
SCH 56592 vs Fluconazole for Oropharyngeal Candidiasis in HIV-Positive Patients
What is being tested
Posaconazole
+ Fluconazole
Drug
Who is being recruted
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: August 1998
Summary
Principal SponsorSchering-Plough
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.
Principal SponsorSchering-Plough
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
300 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 InfectionsOtorhinolaryngologic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCandidiasis, OralPharyngeal DiseasesHIV InfectionsAIDS-Related Opportunistic Infections
Criteria
6 inclusion criteria required to participate
Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms)
Are HIV-positive
Are able to take study medication and return for clinic visits during the study
Are at least 18 years old
Show More Criteria
10 exclusion criteria prevent from participating
Are allergic to azole drugs
Are pregnant or breast-feeding
Cannot take medications by mouth
Have been in this study before
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
ViRx Inc
San Francisco, United StatesKaiser Foundation Hospital
San Francisco, United StatesInfectious Disease and AIDS Clinic
Denver, United StatesCompleted18 Study Centers