A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Po… (NCT00000951) | Clinical Trial Compass
CompletedPhase 4
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
United States, Puerto Rico948 participants
Plain-language 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.
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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
Exclusion Criteria
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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000951
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)