Single dose treatment for asymptomatic cryptococcal antigenemia
Official title: Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Run by Makerere University · NCT03945448 · Data updated 2026-11-12
This study is testing if a single dose of a special antifungal treatment combined with standard care can help people in Uganda with a certain type of fungal infection avoid getting sicker and live longer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 356 (estimated) |
| Sponsor | Makerere University Academic / other |
| Locations | 1 site (Kampala) |
| Status | Recruiting |
| Started | June 20, 2019 |
| Main results expected | June 2027 |
| Study ends | August 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT03945448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include HIV-1 positive individuals aged 15 years or older with a high cryptococcal antigen titer.
✕Probably not a fit
Patients with a history of cryptococcal infection or those currently experiencing symptomatic meningitis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a single dose of liposomal amphotericin combined with standard fluconazole therapy in asymptomatic individuals with cryptococcal antigenemia in Uganda. Participants will be randomly assigned to receive either the enhanced treatment or standard care, and the study will assess the prevention of progression to cryptococcal meningitis and overall survival over a 24-week period. The trial aims to determine if this preemptive approach can improve outcomes compared to the current standard of care.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing cryptococcal meningitis in at-risk patients.
How similar studies have gone: While this approach is novel in this specific context, similar studies have shown promise in enhancing treatment outcomes for cryptococcal infections.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-1 infection * Age \> or equal to15 years * Ability and willingness to give informed consent. * Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater Exclusion Criteria: * Cannot or unlikely to attend regular clinic visits * History of cryptococcal infection * Symptomatic meningitis (confirmed by CSF CRAG+) * \>14 days of fluconazole therapy * Pregnancy (confirmed by urinary or serum pregnancy test) * Current breastfeeding * Known allergy to amphotericin
Where it's running
-
infectious Disease Institute Kampala,Uganda
Kampala, Uganda Recruiting
Study contacts
- Study coordinator: DAVID MEYA, PhD
- Email: david.meya@gmail.com
- Phone: +256 772 543 730
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing antifungal treatment options for cryptococcal meningitis in people with HIV.
This will test several antifungal medicines to see which works best for adults with HIV who have cryptococcal meningitis.
-
Understanding Idiopathic CD4+ Lymphocytopenia and its Effects
This study is trying to understand how Idiopathic CD4+ lymphocytopenia affects people over time by looking at their immune system and any related health issues while they receive standard treatment for infections.
-
Understanding immune responses in patients with cryptococcal infections
This study looks at how the immune system works in healthy adults with cryptococcal infections to see what makes them more likely to get sick.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.