Clinical trial NCT00002399: A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Official title: A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Fluconazole
Antifungal Agents
Candidiasis
Triazoles
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

Detailed description: This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment.
* Pseudomembranous oropharyngeal candidiasis.
* Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture.
* Ability to swallow study medication.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms and conditions are excluded:

* Medical condition requiring use of prohibited drugs.
* Primary HIV seroconversion-related mucosal candidiasis.
* Systemic candidiasis.
* All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC).
* Documented or suspected fungal esophagitis in patients with symptoms of esophagitis.
* EKG with prolonged QTc interval or clinically-significant abnormalities.

Concurrent Medication:

Excluded:

* Systemic antifungals (IV or oral).
* Topical oral antifungals, e.g., Nystatin, Mycelex, etc.
* Medications known to interact with azoles and that may lead to life-threatening side effects:
* terfenadine, astemizole, cisapride, ebastine, triazolam, midazolam.
* Medications known to lower the serum concentration/efficacy of azole antifungals:
* rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, H2 blockers.
* Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment.
* Protease inhibitors, starting for the first time, 30 days prior to study enrollment.
* Cytotoxic therapy for cancer.
* Oral or intravenous corticosteroids at supraphysiologic doses (prednisone 10 mg/day or greater; hydrocortisone 40 mg/day or greater; dexamethasone 2 mg/day or greater.

Patients with any of the following prior conditions are excluded:

* Prior enrollment in this study.
* Less than 3 months life expectancy.
* History of hypersensitivity to azole antifungals.
* History of failed therapy with fluconazole 100 mg/day for 2 weeks in the last 3 months.

Prior Medication:

Excluded (wash-outs for medications):

* Systemic antifungals (IV, oral) within 14 days prior to enrollment.
* Topical oral antifungals within 1 day prior to enrollment.
* Oral or intravenous corticosteroids at supraphysiologic doses within 10 days prior to enrollment.
* Astemizole within 10 days prior to enrollment.
* Drugs known to lower the serum concentration/efficacy of azole antifungals within 30 days prior to enrollment.
* Investigational drug (unlicensed new chemical entity) use within 30 days prior to enrollment.

Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Veterans Administration Med Ctr
state: Arizona
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Miami
country: United States
facility: Mercy Hosp
state: Florida
city: Atlanta
country: United States
facility: Ponce de Leon Med Ctr
state: Georgia
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush Med College / Rush Presbyterian - St Luke's Med Cen
state: Illinois
city: Indianapolis
country: United States
facility: Wishard Hosp
state: Indiana
city: Detroit
country: United States
facility: Wayne State Univ / Harper Hosp
state: Michigan
city: Newark
country: United States
facility: St Michaels Med Ctr
state: New Jersey
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ / Division of Infectious Disease
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr
state: Texas
city: Houston
country: United States
facility: Univ of Texas / Med School at Houston
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Sciences Ctr
state: Texas
city: Tacoma
country: United States
facility: Infections Ltd / Physicians Med Ctr
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro de Micologia / Facultad de Medicina UBA
city: Buenos Aires
country: Argentina
facility: Hosp Fernandez
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Vancouver
country: Canada
facility: St Paul's Hosp
state: British Columbia
city: Halifax
country: Canada
facility: Victoria Gen Hosp
state: Nova Scotia
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arriaran
city: Ensanche NACO/ Santo Domingo
country: Dominican Republic
facility: Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler
city: Addis Ababa
country: Ethiopia
facility: Faculty of Medicine / Dept of Internal Medicine
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Maseille
country: France
facility: Hopital de La Conception
city: Montpellier
country: France
facility: Hopital Guy de Chauliac Service des Maladies Infectieuses
city: Nice
country: France
facility: Service des Maladies Infectieuses Hopital de l Archet
city: Paris cedex
country: France
facility: Hopital de l Institut Pasteur
city: Paris
country: France
facility: Hopital Rothchild
city: Tours Cedex
country: France
facility: Service des Maladies Infectieuses
city: Villejuif Cedex
country: France
facility: Service des Maladies Infectieuses
city: Bonn
country: Germany
facility: Rheinische Friedrich Wilhelms Universitaet Medizinische
city: Dusseldorf
country: Germany
facility: Heinrich Heine Universitat
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus St Georg
city: Hamburg
country: Germany
facility: Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
city: Kiel
country: Germany
facility: Staedtisches Krankenhaus Kiel
city: Koln
country: Germany
facility: Universitaet Klinik Koln
city: Munich 2
country: Germany
facility: Universitat Munchen / Medizinische Poliklinik
city: Guatemala
country: Guatemala
facility: Hosp Roosevelt Chief Infectious Diseases Unit
city: San Pedro Sula
country: Honduras
facility: Hosp Regional del Seguro Social
city: Tel Hashomer
country: Israel
facility: Sheba Med Ctr
city: Mexico
country: Mexico
facility: Hosp de Especialidades Centro Medico La Raza
city: Panama
country: Panama
facility: Royal Ctr
city: Port Elizabeth
country: South Africa
facility: Daniel Rudolph Malan
city: Rosebank
country: South Africa
facility: The Studio
city: Tygerberg
country: South Africa
facility: Univ of Stellenbosch Med School Depart Med Phys
city: Barcelona
country: Spain
facility: Hosp Clinic
city: Barcelona
country: Spain
facility: Hosp Valle D Hebron
city: Bangkok
country: Thailand
facility: Program on AIDS / Thai Red Cross Society
city: Caracas
country: Venezuela
facility: Policlinica Metropolitana
Study officials:
References: