Candidiasis, OralPhase 3NCT00002446
Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
A Phase 3 study testing Posaconazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Schering-Plough at 18 sites in 2 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Posaconazole and Fluconazole
- How many people
- 300 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Aug 1998to not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are at least 18 years old.
- Are HIV-positive.
- Have thrush (oropharyngeal candidiasis).
- Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
- Are able to take study medication and return for clinic visits during the study.
- Are expected to live for at least 2 months.
Who cannot join
- You will not be eligible for this study if you:
- Have received protease inhibitors for the first time within 30 days prior to study entry.
- Have received certain medications.
- Have certain other types of fungal infections.
- Have certain types of cancer.
- Have received SCH 56592 within 3 months prior to study entry.
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- Are pregnant or breast-feeding.
- Cannot take medications by mouth.
- Are allergic to azole drugs.
- Have certain medical conditions.
- Have been in this study before.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
East Bay AIDS Ctr
Berkeley, California, 94705
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, 11203
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103
Med Univ of South Carolina
Charleston, South Carolina, 29425
TRIAD Health Practice
Chicago, Illinois, 60657
Amelia Ct Clinic
Dallas, Texas, 75235
Infectious Disease and AIDS Clinic
Denver, Colorado, 80204
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
Community Hosp Indianapolis
Indianapolis, Indiana, 46219
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
Jersey City Med Ctr
Jersey City, New Jersey, 07304
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Univ of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
ViRx Inc
San Francisco, California, 94109
Kaiser Foundation Hospital
San Francisco, California, 94118
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
Barbados1 site
Queen Elizabeth Hosp Respiratory Unit
Saint Michael
About this study
Official title: Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
Read the detailed description
Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Posaconazole, Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Administration, Oral, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, posaconazole
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic Infections, Pharyngeal Diseases
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)
- Study startAug 1998
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 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002446
- Sponsor's protocol ID
- 305A
- Other IDs
- C97-331, I97-331
- Status last verified
- Feb 2000
- 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
- Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
- ClinicalTrials.gov ID
- NCT00002446
- Acronym / sponsor ID
- 305A
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Administration, Oral, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, posaconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- 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 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
Detailed description
Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years old.
- Are HIV-positive.
- Have thrush (oropharyngeal candidiasis).
- Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
- Are able to take study medication and return for clinic visits during the study.
Key exclusion criteria (11 listed)
- Have received protease inhibitors for the first time within 30 days prior to study entry.
- Have received certain medications.
- Have certain other types of fungal infections.
- Have certain types of cancer.
- Have received SCH 56592 within 3 months prior to study entry.
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.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Posaconazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Schering-Plough at 18 sites in 2 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 7 inclusion and 11 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 18 sites in United States, Barbados. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.