Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timi… (NCT07743593) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Uganda505 participantsStarted 2026-09-01
Plain-language summary
This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.
Participants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.
Participants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.
Who can participate
Age range
18 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:
* HIV-1 infection
* Age greater than 18 years
* Ability and willingness to give informed consent
* Plasma or serum cryptococcal antigen positive with titer less than 1:160
Exclusion Criteria:
* Cannot or unlikely to attend regular clinic visits
* History of cryptococcal infection
* Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity
* More than 10 weeks of fluconazole therapy
* Pregnancy confirmed by urinary or serum pregnancy test
* Current breastfeeding
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.
1This trial is testing a short-course fluconazole approach for people who test positive for the cryptococcal antigen but have low titers — does my current antigen titer level and overall situation make me a potential candidate worth discussing with you?
2The trial is Phase 3 and not yet recruiting, so what does that mean for my timeline — should I be starting standard treatment now, and could I still explore this trial once it opens without missing a critical window?
3The trial is measuring whether people survive 24 weeks without developing cryptococcal meningitis while staying in care, which tells me meningitis progression is a real risk — how closely would I need to be monitored for signs of that, whether I'm in this trial or on a standard treatment path?
4One of the trial's key goals is 10-week hospitalization-free survival, which suggests the early weeks carry meaningful risk — what warning signs should I watch for at home during that period, and how quickly should I seek emergency care?
5Since this trial is specifically about people with low antigen titers, can you explain how my titer level compares and whether that affects whether short-course fluconazole versus a longer standard regimen is the safer choice for me right now?
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.
What they're measuring
1
24-week cryptococcal meningitis-free survival with retention in care
Timeframe: 24 weeks
2
10-week hospitalization-free survival with retention in care