Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Launched by MAKERERE UNIVERSITY · May 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have a type of fungal infection called cryptococcal antigenemia, which can sometimes lead to a serious condition known as cryptococcal meningitis. The trial will take place in Uganda and aims to find out if giving patients a one-time dose of a drug called liposomal amphotericin, along with standard treatment using fluconazole, can help prevent the infection from getting worse over 24 weeks and improve survival rates compared to those who only receive fluconazole.

To participate in the trial, you must be at least 15 years old, have a confirmed HIV-1 infection, and test positive for cryptococcal antigens at a certain level. However, if you have had a previous cryptococcal infection or are currently experiencing symptoms of meningitis, you would not be eligible. Participants will receive either the new treatment or standard care and will be monitored regularly to see how well the treatment works. This trial is important as it could lead to better ways to manage and treat this serious fungal infection.

Gender

ALL

Eligibility 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