Candidiasis, OralNCT00002057
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
A study testing Nystatin in people with Candidiasis, Oral and HIV Infections, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Nystatin
- How many people
- Not given
- Where
- 2 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Systemic or oral antibiotics.
- Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.
- Patients with the following conditions are included:
- AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
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- Able to follow instructions regarding the use of a pastille.
- Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
- Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Systemic candidiasis.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
- Patients with the following are excluded:
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- Systemic candidiasis.
- Projected survival of less than 6 months.
- Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, 35233
Bristol - Myers Squibb Co
Princeton, New Jersey, 085434000
About this study
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Nystatin
- Keywords
- Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic 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.
NystatinDrug
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.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002057
- Sponsor's protocol ID
- 026A
- Other IDs
- 4
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
- ClinicalTrials.gov ID
- NCT00002057
- Acronym / sponsor ID
- 026A
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (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 determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Systemic or oral antibiotics.
- Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.
- AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
- Able to follow instructions regarding the use of a pastille.
- Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
Key exclusion criteria (11 listed)
- Systemic candidiasis.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
- Systemic candidiasis.
- Projected survival of less than 6 months.
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 |
|---|---|---|
| Nystatin | 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 2 Oct 2007.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nystatin in people with Candidiasis, Oral and HIV Infections, run by Bristol-Myers Squibb at 2 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 9 inclusion and 11 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 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 2 Oct 2007.