FindTrial
Sign In

MULTICENTRIC, DOUBLE-BLIND, FOUR-PARALLEL GROUP, RANDOMIZED STUDY TO INVESTIGATE THE RESPONSE DOSE OF MICAFUNGIN (FK463) COMPARED WITH FLUCONAZOLE, ADMINISTERED TO HIV-POSITIVE PATIENTS WITH CONFIRMED CANDIDIASIS ESOPHAGITIS

MULTICENTRIC, DOUBLE-BLIND, FOUR-PARALLEL GROUP, RANDOMIZED STUDY TO INVESTIGATE THE RESPONSE DOSE OF MICAFUNGIN (FK463) COMPARED WITH FLUCONAZOLE, ADMINISTERED TO HIV-POSITIVE PATIENTS WITH CONFIRMED CANDIDIASIS ESOPHAGITIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-033-02
Enrollment
Unknown
Registered
2002-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

FK 463 50mg/dia Type of group
It is administered during 14-21 days of FK 463 50mg / day for the treatment of candidiasis esophagitis in HIV positive patients. Group name:fluconazole 200 mg/ day Type of group
It is administered during 14-21 days of fluconazole 200 mg/ day y for the treatment of candidiasis esophagitis in HIV positive patients.

Sponsors

FUJISAWAGMBH (ALEMANIA),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: HIV-positive male or female patients, aged 18 years or older, diagnosed with candidiasic esophagitis confirmed by endoscopy

Exclusion criteria

Exclusion criteria: underage pregnant women

Design outcomes

Primary

MeasureTime frame
Outcome name:Through endoscopy Measure:The response rate, defined as the proportion of patients with endoscopic evaluation of grade O at the end of the therapy. Timepoints:21 day—

Secondary

MeasureTime frame
Outcome name:though endoscopy Measure:Proportion of patients with endoscopic evaluation of grade O to Day 14 of the Treatment Timepoints:14 day—

Countries

Belgium, Brazil

Outcome results

None listed

Source: REPEC (via WHO ICTRP)