Candidiasis, EsophagealNCT00002304
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
A study testing Ketoconazole and Fluconazole in people with Candidiasis, Esophageal and HIV Infections, run by Pfizer at 42 sites in 2 countries.
Trial summary
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Candidiasis, Esophageal, HIV Infections
- What is being tested?
- Ketoconazole and Fluconazole
- How many people
- Not given
- Where
- 42 sitesin 2 countries
- 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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prior Medication:
- Allowed:
- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of noncandidal systemic fungal infections.
- Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
- Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
- Leukemia requiring chemotherapy.
Show all 28Show fewer
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
- Concurrent Medication:
- Excluded:
- Warfarin.
- Immunostimulants.
- Interferon.
- Oral or topical antifungal agents.
- Concurrent Treatment:
- Excluded:
- Lymphocyte replacement.
- Patients with the following are excluded:
- History of allergy to imidazoles.
- Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
- Inability to tolerate fluconazole or ketoconazole.
- Inability or unwillingness to give written informed consent.
- Life expectancy < 2 months.
- Prior Medication:
- Excluded:
- Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
- Warfarin.
- Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.
- Illicit or illegal drug use.
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States41 sites
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Georgia Baptist Med Ctr
Atlanta, Georgia, 30338
Leila Hosp and Health Care Ctr
Battle Creek, Michigan, 49016
Univ Hosp
Boston, Massachusetts, 02118
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Roswell Park Memorial Institute
Buffalo, New York, 14263
Baroness Erlanger Hosp
Chattanooga, Tennessee, 37403
Regional Oncology Ctr
Daytona Beach, Florida, 32015
DeKalb Gen Hosp
Decatur, Georgia, 30033
Harper Hosp
Detroit, Michigan, 48201
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Butterworth Hosp
Grand Rapids, Michigan, 49503
Holland Community Hosp
Holland, Michigan, 49423
Mem Hosp Hollywood
Hollywood, Florida, 33021
Dr Eugene Speck
Las Vegas, Nevada, 89109
Gwinnett Med Ctr
Lawrenceville, Georgia, 30245
Arkansas Children's Hosp
Little Rock, Arkansas, 72202
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Tennessee
Memphis, Tennessee, 38163
Cornell Univ Med Ctr
New York, New York, 10021
Med Ctr Clinic
Pensacola, Florida, 325241151
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Good Samaritan Med Ctr
Phoenix, Arizona, 85006
Eisenhower Med Ctr
Rancho Mirage, California, 92270
McGuire Virginia Med Ctr
Richmond, Virginia, 23249
Atlanta Hosp
Riverdale, Georgia, 30274
Clayton Gen Hosp
Riverdale, Georgia, 30274
Dr Winkler Weinberg
Roswell, Georgia, 30076
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
ViRx Inc
San Francisco, California, 94103
UCSF Hosp
San Francisco, California, 941430654
Virginia Mason Med Ctr
Seattle, Washington, 98101
Wilson Brailsford Clinic
Spartanburg, South Carolina, 29304
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
St Petersburg Med Clinics
St. Petersburg, Florida, 33705
Munson Med Ctr
Traverse City, Michigan, 49684
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Being tested
- Ketoconazole, Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
- Medical subject headings
- Candidiasis, HIV Infections, AIDS-Related Opportunistic Infections, Esophagitis, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoconazoleDrug
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002304
- Sponsor's protocol ID
- 012B
- Other IDs
- 056-150
- Status last verified
- Feb 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. doi: 10.7326/0003-4819-117-8-655.
PubMed 1308663
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 Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT00002304
- Acronym / sponsor ID
- 012B
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (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 compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
Key exclusion criteria (28 listed)
- Evidence of noncandidal systemic fungal infections.
- Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
- Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
- Leukemia requiring chemotherapy.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
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 |
|---|---|---|
| Ketoconazole | 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 1308663Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. doi: 10.7326/0003-4819-117-8-655.
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.
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketoconazole and Fluconazole in people with Candidiasis, Esophageal and HIV Infections, run by Pfizer at 42 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 3 inclusion and 28 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 42 sites in United States, Canada. 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 NCT00002304, 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.