Candidiasis, OralPhase 4NCT00000951
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
A Phase 4 study testing Fluconazole in people with Candidiasis, Oral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush. 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?
- Fluconazole
- How many people
- 948 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Start not givento May 2002
- Phase
- Phase 4
- 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4+ cell count less than 150 cells/mm3.
- Had at least one episode of thrush in the 24 months before study entry.
- Have a life expectancy of at least 12 months.
- Weigh at least 88 pounds.
- Are 13 years of age or older (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have an allergy to azoles.
- Have had 3 episodes or more of thrush within 12 weeks of study entry.
- Have a history of esophageal candidiasis.
- Have a history of fluconazole-resistant infection.
- Have an active opportunistic infection requiring treatment within 14 days before study entry.
Show all 11Show fewer
- Have a fungal infection requiring certain medications.
- Have a severe liver disease (e.g., cirrhosis).
- Are unable to tolerate oral medications.
- Take certain medications.
- Are pregnant or breast-feeding.
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States53 sites
Emory Univ
Atlanta, Georgia, 30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Boston Med Ctr
Boston, Massachusetts, 02118
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Texas Galveston
Galveston, Texas, 775550435
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 331361013
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
Univ of Minnesota
Minneapolis, Minnesota, 55455
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Saint Clare's Hosp and Health Ctr
New York, New York, 10019
Cornell Univ Med Ctr
New York, New York, 10021
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
Univ of Rochester Medical Center
Rochester, New York, 14642
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 98104
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
Albert Einstein College of Medicine
The Bronx, New York, 10461
Howard Univ
Washington D.C., District of Columbia, 20059
Institute for Clinical Research
Washington D.C., District of Columbia, 20422
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush.
Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.
Read the detailed description
This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections.
Prior to randomization to a long-term management strategy using fluconazole, patients are stratified into one of three groups according to their baseline CD4+ count (cells/mm3): 0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at enrollment and those patients who respond (no thrush present) to the initial acute therapy for an active infection are randomized 1:1 to one of two management strategies for fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous fluconazole). Patients are then followed for a duration of 24 months after enrollment of the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present) are then randomized to a long-term management strategy. Those who do not respond (refractory disease) to the acute treatment are permanently discontinued from the study. Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Antifungal Agents, Candidiasis, Oral, Drug Administration Schedule, Pharyngeal Diseases
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic Infections, Pharyngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
- Study completionMay 2002
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, 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 948 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Mitchell Goldman, Study chairScott G. Filler, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000951
- Sponsor's protocol ID
- ACTG 323
- Other IDs
- 11297
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Swindells S, Evans S, Zackin R, Goldman M, Haubrich R, Filler SG, Balfour HH Jr; AIDS Clinical Trial Group 722 Study Team. Predictive value of HIV-1 viral load on risk for opportunistic infection. J Acquir Immune Defic Syndr. 2002 Jun 1;30(2):154-8. doi: 10.1097/00042560-200206010-00003.
PubMed 12045677
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis
- ClinicalTrials.gov ID
- NCT00000951
- Acronym / sponsor ID
- ACTG 323
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Antifungal Agents, Candidiasis, Oral, Drug Administration Schedule, Pharyngeal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Washington University School of Medicine
- Study completion
- May 2002 (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.
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush.
Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.
Detailed description
This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections.
Prior to randomization to a long-term management strategy using fluconazole, patients are stratified into one of three groups according to their baseline CD4+ count (cells/mm3): 0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at enrollment and those patients who respond (no thrush present) to the initial acute therapy for an active infection are randomized 1:1 to one of two management strategies for fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous fluconazole). Patients are then followed for a duration of 24 months after enrollment of the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present) are then randomized to a long-term management strategy. Those who do not respond (refractory disease) to the acute treatment are permanently discontinued from the study. Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Have a CD4+ cell count less than 150 cells/mm3.
- Had at least one episode of thrush in the 24 months before study entry.
- Have a life expectancy of at least 12 months.
- Weigh at least 88 pounds.
Key exclusion criteria (11 listed)
- Have an allergy to azoles.
- Have had 3 episodes or more of thrush within 12 weeks of study entry.
- Have a history of esophageal candidiasis.
- Have a history of fluconazole-resistant infection.
- Have an active opportunistic infection requiring treatment within 14 days before study entry.
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 |
|---|---|---|
| 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 29 Oct 2021.
- Background: PubMed 12045677Swindells S, Evans S, Zackin R, Goldman M, Haubrich R, Filler SG, Balfour HH Jr; AIDS Clinical Trial Group 722 Study Team. Predictive value of HIV-1 viral load on risk for opportunistic infection. J Acquir Immune Defic Syndr. 2002 Jun 1;30(2):154-8. doi: 10.1097/00042560-200206010-00003.
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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.
Mitchell Goldman study chair
Scott G. Filler study chair
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluconazole in people with Candidiasis, Oral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 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 8 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
On the ClinicalTrials.gov record for NCT00000951, 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 29 Oct 2021.