Single dose treatment for asymptomatic cryptococcal antigenemia
Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
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 |
| Enrollment | 356 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Makerere University Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT03945448 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include HIV-1 positive individuals aged 15 years or older with a high cryptococcal antigen titer.
Not a fit: Patients with a history of cryptococcal infection or those currently experiencing symptomatic meningitis will not benefit from this study.
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 performed: While this approach is novel in this specific context, similar studies have shown promise in enhancing treatment outcomes for cryptococcal infections.
Eligibility criteria
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 this trial is running
Kampala
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.