Candidiasis, EsophagealNCT00002132
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
A study testing Itraconazole and Fluconazole in people with Candidiasis, Esophageal and HIV Infections, run by Janssen Pharmaceuticals at 18 sites in United States.
Trial summary
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Candidiasis, Esophageal, HIV Infections
- What is being tested?
- Itraconazole and Fluconazole
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Esophageal candidiasis.
- Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
- HIV infection or other predisposing risk factor.
- Life expectancy of at least 2 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
- Evidence of systemic fungal infection.
- Underlying clinical condition that would preclude study completion.
- Judged to be unreliable in regard to following physician's directives.
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- Concurrent Medication:
- Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Terfenadine.
- Astemizole.
- H2 blockers.
- Continual antacids.
- Any investigational drug (expanded access drugs are allowed).
- Patients with the following prior conditions are excluded:
- History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
- History of hypersensitivity to imidazole or azole compounds.
- Prior Medication:
- Excluded:
- Other orally administered antifungal therapy within 3 days prior to study entry.
- Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Austin Infectious Disease Consultants
Austin, Texas, 78705
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
Erie County Med Ctr
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 27599
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, 64132
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Dr Douglas Dieterich
New York, New York, 10016
UCSD Med Ctr
San Diego, California, 92103
Montefiore Med Ctr
The Bronx, New York, 10467
Dr Eskild A Petersen
Tucson, Arizona, 85724
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 27157
About this study
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Being tested
- Itraconazole, Fluconazole
- Keywords
- Itraconazole, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Immunocompromised Host
- Medical subject headings
- Candidiasis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, EsophagealStudies 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002132
- Sponsor's protocol ID
- 236A
- Other IDs
- ITR-USA-12
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7. doi: 10.3109/00365549509047076.
PubMed 8685642
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, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
- ClinicalTrials.gov ID
- NCT00002132
- Acronym / sponsor ID
- 236A
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Keywords
- Itraconazole, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Immunocompromised Host
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Janssen PharmaceuticalsIndustry (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 evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Esophageal candidiasis.
- Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
- HIV infection or other predisposing risk factor.
- Life expectancy of at least 2 months.
Key exclusion criteria (25 listed)
- Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
- Evidence of systemic fungal infection.
- Underlying clinical condition that would preclude study completion.
- Judged to be unreliable in regard to following physician's directives.
- Rifampin.
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 | – |
| 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.
- Background: PubMed 8685642Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7. doi: 10.3109/00365549509047076.
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 and Fluconazole in people with Candidiasis, Esophageal and HIV Infections, run by Janssen Pharmaceuticals 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 5 inclusion and 25 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 NCT00002132, 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.