Candidiasis, OralNCT00002133
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
A study testing Itraconazole in people with Candidiasis, Oral and HIV Infections, run by Janssen, LP at 18 sites in United States.
Trial summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole. 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?
- Itraconazole
- How many people
- Not given
- Where
- 18 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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:
- 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.
Who cannot join
- 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:
Show all 20Show fewer
- 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).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
East Bay AIDS Ctr
Berkeley, California, 94705
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, 20892
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
Ohio State Univ Hosp
Columbus, Ohio, 43210
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, 72205
Infectious Disease Clinic
Nashville, Tennessee, 37212
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, 73104
Pennsylvania Hosp
Philadelphia, Pennsylvania, 19107
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Washington Univ
St Louis, Missouri, 63108
Dr Douglas Ward
Washington D.C., District of Columbia, 20009
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
About this study
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Read the 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.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Itraconazole
- Keywords
- Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Medical subject headings
- Candidiasis, Oral, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002133
- Sponsor's protocol ID
- 236B
- Other IDs
- ITR-USA-94
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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)
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
- An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
- ClinicalTrials.gov ID
- NCT00002133
- Acronym / sponsor ID
- 236B
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Janssen, LPIndustry (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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- Underlying clinical condition that precludes study completion or places the patient at significant risk.
- Considered unreliable about following physician's directives.
- Investigational drugs (approved expanded access drugs are permitted).
- Rifampin.
- Rifabutin.
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 |
|---|---|---|
| Itraconazole | 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.
- BackgroundMoskovitz 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)
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itraconazole in people with Candidiasis, Oral and HIV Infections, run by Janssen, LP at 18 sites in United States.
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 20 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. 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.
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?
On the ClinicalTrials.gov record for NCT00002133, which also lists 1 linked publication.
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.