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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV-1 who have a low-level positive cryptococcal antigen blood test. It compares shorter and longer fluconazole treatment and the timing of HIV treatment.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Cryptococcal antigen positive in plasma or serum, with a titer less than 1:160, and no confirmed symptomatic meningitis.
- Earlier treatment
- People with more than 10 weeks of fluconazole therapy cannot join.
- Biomarker or test result
- Plasma or serum cryptococcal antigen positive with titer less than 1:160. HIV-1 infection.
Main reasons for not taking part
- 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
Read by machine on 12 November 2026.
Where in Uganda
- Infectious Diseases Institute, Makerere UniversityKampala, UgandaContact: Radha Rajasingham, MDNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.