Clinical trial NCT00002133: An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Official title: An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: Itraconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Detailed description: Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV antibody seropositivity or diagnosis of AIDS.
* Confirmed oropharyngeal candidiasis.
* Failed fluconazole treatment within the past 14 days.
* Life expectancy of at least 3 months.
* NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
* NO prior disseminated candidiasis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Underlying clinical condition that precludes study completion or places the patient at significant risk.
* Considered unreliable about following physician's directives.

Concurrent Medication:

Excluded:

* Investigational drugs (approved expanded access drugs are permitted).
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.

Patients with the following prior conditions are excluded:

* History of hypersensitivity to imidazole or azole compounds.
* Clinical evidence of significant hepatic disease within the past 2 months.

Prior Medication:

Excluded:

* Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Univ of Arkansas for Med Sciences
state: Arkansas
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: Washington
country: United States
facility: Dr Douglas Ward
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Indianapolis
country: United States
facility: Infectious Diseases Research Clinic / Indiana Univ Hosp
state: Indiana
city: Bethesda
country: United States
facility: Natl Inst of Allergy & Infect Dis / Cln Ctr
state: Maryland
city: Ann Arbor
country: United States
facility: Ann Arbor Veterans Administration Med Ctr
state: Michigan
city: Detroit
country: United States
facility: Wayne State Univ / Harper Hosp
state: Michigan
city: St. Louis
country: United States
facility: Washington Univ
state: Missouri
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City Veterans Administration Med Ctr
state: Oklahoma
city: Philadelphia
country: United States
facility: Pennsylvania Hosp
state: Pennsylvania
city: Nashville
country: United States
facility: Infectious Disease Clinic
state: Tennessee
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
city: Charlottesville
country: United States
facility: Univ of Virginia Health Sciences Ctr
state: Virginia
Study officials:
References:
citation: Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325)