RANDOMIZED DOUBLE-BLIND STUDY ON THE EFFICACY AND SAFETY OF BMS - 207147 IN RELATION TO FLUCONAZOLE IN THE TREATMENT OF IMMUNOCOMPROMISED PATIENTS WITH ESOPHAGEAL CANDIDIASIS

Not Applicable

• Conditions: -B378 Candidiasis of other sites; Candidiasis of other sites; B378

• Registration Number: PER-019-00
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-03-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients with HIV infection or who are otherwise immunocompromised (malignancy, transplant, chronic steroid use >10 mg/day of prednisone, etc.);
• Clinical diagnosis of EC characterized by one or more of the following symptoms: dysphagia, odynophagia, retrosternal discomfort;
• Endoscopically confirmed diagnosis of EC;
• Mycological evidence of EC, characterized by hyphae or pseudohyphae from esophageal scraping, brushing, smear or biopsy; or, positive culture for yeast;
• Age >16 years or minimal legal age in the given country;
• Able to provide written informed consent;
• Able to comply with protocol requirements; and
• Males or non-pregnant, non-lactating women.

Exclusion Criteria

• More than one day of systemic antifungal therapy, or three days of topical therapy (e.g., troches), within 7 days prior to dosing;
• Patients with oropharyngeal or esophageal candidiasis refractory to azoles (e.g., failure to respond to > 200 mg/day, of fluconazole or itraconazole, for a 10 day treatment course in the past 3 months);
• Documented or suspected systemic fungal infection other than oral thrush or esophagitis;
• Unable to swallow any solids or liquids;
• History of intolerance or allergy to azole antifungal agents;
• Pregnant or nursing females; or WOCBP unwilling to use an effective method of contraception;
• Concomitant use, or treatment within the previous 1 month with other investigational drugs or biologics, unless they are for the treatment of HIV infection or the treatment of an active malignancy;
• Patients with immediately life-threatening or rapidly progressive conditions, or with a life expectancy of less than two months;
• Use of an agent known to prolong QTc-interval (e.g., astemizole, terfenadine, cisapride) within 2 weeks prior to enrollment or the expected need for such therapy within six weeks after the last dose of study drug;
• Liver function tests - LFT - (i.e., AST/SGOT, ALT/SGPT, alkaline phosphate or total bilirubin) > 3.0 ULN or other evidence of unstable hepatic disease;
• Serum creatinine > 2.0 ULN or other evidence of unstable renal disease;
• Evidence of unstable cardiovascular, pulmonary, endocrine, neurological or other illness;
• Any clinical condition or prior therapy which, in the opinion of the investigator, would make the subject unsuitable for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Frequency tables will be used to summarize clinical and mycologic response by study medication at Test of Cure assessment and follow up visits. Clinical cure rates for BMS-207147 and fluconazole at the Test of Cure Visit will be estimated using 95% exact confidence intervals. Efficacy results will be evaluated with respect to underlying risk factors found in this immunocompromised population.<br>Measure:Efficacy<br>Timepoints:During follow up<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:All subjects enrolled in this study who received at least one dose of study medication will be evaluated for safety. Clinical observations and laboratory data collected from the time of initial dosing until study completion or discontinuation will be compared to baseline values established prior to the first dose of study medication. Adverse events will be graded by the investigator as mild, moderate, severe or very severe. In addition, attempts<br>will be made to discem to what extent side effects are<br>related to study durig administration (ranging from certain to unrelated).<br>Measure:Safety<br>Timepoints:During the whole study<br>