Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers

Starting soon · Phase 3

Conditions studied: Cryptococcal Antigenemia, HIV-1-infection, Cryptococcal Infection, Cryptococcal Meningitis

In brief

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.

Key facts

Study ID

NCT07743593

Run by

University of Minnesota

People needed

505

Starts

2026-09-01

Expected to finish

2031-08-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Infectious Diseases Institute, Makerere University — Kampala, Uganda

Full record on ClinicalTrials.gov

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