Shorter fluconazole and HIV treatment timing in adults with low-level cryptococcal antigen
Compares a shorter and standard fluconazole course, and early or delayed HIV treatment, in adults.
Plain-language title generated from the registry record
Registry title: Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Key facts
- Where
- Kampala, UgandaSee the site
- Phase
- Phase 3
Where in Uganda
- Infectious Diseases Institute, Makerere UniversityKampala, UgandaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Minnesota
- Trial code
- NCT07743593
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
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.
Inclusion: 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: More than 10 weeks of fluconazole therapy; History of cryptococcal infection; Pregnancy confirmed by urinary or serum pregnancy test; Cannot or unlikely to attend regular clinic visits; Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity; Current breastfeeding.