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NCT07743593Not yet recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
505 (estimated)
First submitted
30 Jul 2026
Start date
5 Jan 2027
Primary completion date
30 Aug 2031
Lead sponsor
University of Minnesota
Diseases
HIV
NCT number
NCT07743593

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 505
  • From 5 Jan 2027 to the primary completion date, 30 Aug 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • More than 10 weeks of fluconazole therapy

Other illness

  • History of cryptococcal infection

Lab values

  • Pregnancy confirmed by urinary or serum pregnancy test

Other

  • Cannot or unlikely to attend regular clinic visits
  • Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity
  • Current breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Infectious Diseases Institute, Makerere University
Coordinator of this site? Confirm its status
KampalaUgandaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.