Candidiasis, Esophageal, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Esophagitis, Acquired Immunodeficiency Syndrome, Amphotericin B, Candidiasis, Oral
Brief summary
To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.
Interventions
DRUGAmphotericin B
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Exclusion criteria
Co-existing Condition: Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded. Concurrent Medication: Excluded: * Systemic administration of amphotericin B for a proven or suspected systemic fungal infection. Patients with the following are excluded: * Documented Candida fungemia. * Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis. * Systemic administration of amphotericin B for a proven or suspected systemic fungal infection. * Patient refusal to enter study. Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis. * Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy. * Informed consent must be signed and obtained.
Countries
United States
Outcome results
None listed