Candidiasis, OralPhase 2NCT00002399
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
A Phase 2 study testing Posaconazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Schering-Plough at 53 sites in 18 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Posaconazole and Fluconazole
- How many people
- 500 participants
- Where
- 53 sitesin 18 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 34Show fewer
- 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.
Trial locations and contacts
53 sites in 18 countries.
53 sites in 18 countries
United States17 sites
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308
Med College of Georgia
Augusta, Georgia, 30912
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, 60612
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Texas / Med School at Houston
Houston, Texas, 77030
Wishard Hosp
Indianapolis, Indiana, 46202
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Mercy Hosp
Miami, Florida, 33133
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302
St Michaels Med Ctr
Newark, New Jersey, 07102
Thomas Jefferson Univ / Division of Infectious Disease
Philadelphia, Pennsylvania, 19107
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85723
France8 sites
Hopital Raymond Poincare
Garches
Hopital de La Conception
Maseille
Hopital Guy de Chauliac Service des Maladies Infectieuses
Montpellier
Service des Maladies Infectieuses Hopital de l Archet
Nice
Hopital de l Institut Pasteur
Paris
Hopital Rothchild
Paris
Service des Maladies Infectieuses
Tours
Service des Maladies Infectieuses
Villejuif
Germany7 sites
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn
Universitaet Klinik Koln
Cologne
Heinrich Heine Universitat
Düsseldorf
Allgemeines Krankenhaus St Georg
Hamburg
Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
Hamburg
Staedtisches Krankenhaus Kiel
Kiel
Universitat Munchen / Medizinische Poliklinik
Munich
Canada3 sites
Victoria Gen Hosp
Halifax, Nova Scotia
Montreal Gen Hosp
Montreal, Quebec
St Paul's Hosp
Vancouver, British Columbia
South Africa3 sites
Daniel Rudolph Malan
Port Elizabeth
The Studio
Rosebank
Univ of Stellenbosch Med School Depart Med Phys
Tygerberg
Argentina2 sites
Centro de Micologia / Facultad de Medicina UBA
Buenos Aires
Hosp Fernandez
Buenos Aires
Dominican Republic1 site
Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler
Ensanche Naco/ Santo Domingo
Guatemala1 site
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala City
About this study
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
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.
Read the 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.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Posaconazole, Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Antifungal Agents, Candidiasis, Triazoles
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic Infections, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosaconazoleDrug
FluconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002399
- Sponsor's protocol ID
- 288A
- Other IDs
- C96-209, I96-209
- Status last verified
- Jan 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002399
- Acronym / sponsor ID
- 288A
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Antifungal Agents, Candidiasis, Triazoles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posaconazole | Drug | – |
| Fluconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posaconazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Schering-Plough at 53 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, France, Germany, Canada, South Africa and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.