Candidiasis, OralNCT00002341
A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole
A study testing Itraconazole in people with Candidiasis, Oral and HIV Infections, run by Janssen, LP at 1 site in United States.
Trial summary
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed. 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
- 1 siteUnited 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:
- Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
- Life expectancy of at least 3 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Underlying clinical condition that would preclude completion of study or place subject at significant risk.
- Judged unreliable with respect to physician's directives.
- Concurrent Medication:
- Excluded:
Show all 21Show fewer
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Terfenadine.
- Astemizole.
- Systemic antifungals.
- Patients with the following prior conditions are excluded:
- Previously documented disseminated candidiasis.
- Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
- History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.
- Prior Medication:
- Excluded:
- Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Read the detailed description
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
- 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 (2)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
- NCT00002341
- Sponsor's protocol ID
- 236C
- Other IDs
- ITR-USA-107
- 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)
Fessel WJ, Merrill KW, Ward D, Moskovitz B, Benken C, Oleka N, Grimwood H. Itraconazole oral solution (IS) for the treatment of fluconazole-refractory oropharyngeal candidiasis (OC) in HIV-positive patients. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 327)
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-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution
- ClinicalTrials.gov ID
- NCT00002341
- Acronym / sponsor ID
- 236C
- 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 provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Detailed description
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
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 (3 listed)
- Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
- Life expectancy of at least 3 months.
Key exclusion criteria (21 listed)
- Underlying clinical condition that would preclude completion of study or place subject at significant risk.
- Judged unreliable with respect to physician's directives.
- Rifampin.
- Rifabutin.
- Phenobarbital.
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)
- BackgroundFessel WJ, Merrill KW, Ward D, Moskovitz B, Benken C, Oleka N, Grimwood H. Itraconazole oral solution (IS) for the treatment of fluconazole-refractory oropharyngeal candidiasis (OC) in HIV-positive patients. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 327)
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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.
1 site 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 1 site 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 3 inclusion and 21 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 1 site 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 NCT00002341, which also lists 2 linked publications.
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.