Candidiasis, OralPhase 2NCT00001065
A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole
A Phase 2 study testing Amphotericin B in people with Candidiasis, Oral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 32 sites in 3 countries.
Trial summary
To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension. Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Amphotericin B
- How many people
- 70 participants
- Where
- 32 sitesin 3 countries
- Study dates
- Start not givento Apr 1998
- Phase
- Phase 2
- 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:
- HIV infection OR diagnosis of AIDS.
- Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.
- Perioral lesions only (e.g., angular stomatitis, perleche).
- Inability to swish and swallow oral solution.
- Inability to tolerate further oral therapy for thrush.
Show all 30Show fewer
- Concurrent Medication:
- Excluded:
- Fluconazole.
- Itraconazole.
- Ketoconazole.
- Flucytosine.
- Intravenous amphotericin or other non-study formulations.
- Nystatin.
- Clotrimazole.
- Other investigational antifungal agents.
- Systemic cytotoxic chemotherapy for malignancy.
- Concurrent Treatment:
- Excluded:
- Radiation therapy to the mouth, neck, or chest.
- Patients with the following prior conditions are excluded:
- Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.
- Successful treatment of thrush with fluconazole at <= 200 mg/day after original treatment failure.
- History of oral candidiasis that recurred or persisted despite IV amphotericin B given once or more weekly.
- History of anaphylaxis to amphotericin B.
- History of hypersensitivity to components in amphotericin B oral suspension.
- Prior Medication:
- Excluded within 6 weeks prior to study entry:
- Cytotoxic therapy for malignancy.
- Corticosteroids at higher than replacement doses.
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States30 sites
The Ponce de Leon Ctr. CRS
Atlanta, Georgia
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Bmc Actg Crs
Boston, Massachusetts, 02118
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Weiss Memorial Hosp.
Chicago, Illinois, 60640
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California
Univ. of Miami AIDS CRS
Miami, Florida
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10029
NY Univ. HIV/AIDS CRS
New York, New York
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 68198
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Santa Clara Valley Med. Ctr.
San Jose, California
San Mateo County AIDS Program
San Mateo, California
University of Washington AIDS CRS
Seattle, Washington, 98122
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20059
About this study
Official title: A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Read the detailed description
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Amphotericin B
- Keywords
- Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Candidiasis, Oral, Suspensions
- 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.
Amphotericin BDrug
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 completionApr 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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Enrolment
- 70 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Zingman BS, Study chairWheat LJ, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001065
- Sponsor's protocol ID
- ACTG 295
- Other IDs
- 11271
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00001065
- Acronym / sponsor ID
- ACTG 295
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Candidiasis, Oral, Suspensions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb
- Study completion
- Apr 1998 (actual)
- 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 response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Detailed description
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infection OR diagnosis of AIDS.
- Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.
Key exclusion criteria (30 listed)
- Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.
- Perioral lesions only (e.g., angular stomatitis, perleche).
- Inability to swish and swallow oral solution.
- Inability to tolerate further oral therapy for thrush.
- Fluconazole.
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 |
|---|---|---|
| Amphotericin B | 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 1 Nov 2021.
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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.
Zingman BS study chair
Wheat LJ study chair
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amphotericin B in people with Candidiasis, Oral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 32 sites in 3 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 30 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico, Tanzania. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Nov 2021.