A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002399
• Other study ID #: 288A
• Secondary ID: C96-209I96-209
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections

Intervention

Drug:
• Posaconazole

• Fluconazole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Belgium,  Canada,  Chile,  Dominican Republic,  Ethiopia,  France,  Germany,  Guatemala,  Honduras,  Israel,  Mexico,  Panama,  South Africa,  Spain,  Thailand,