Project Overview
Project title: Fluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening:
A phase III randomised controlled trial
Abbreviation: Efficacy of Flucytosine and Fluconazole as Early Cryptococcal Treatment
ISRCTN: ISRCTN30579828
The EFFECT trial is a phase 3 open-label randomised control trial investigating whether the addition of flucytosine to standard fluconazole therapy for HIV-associated cryptococcal antigenaemia (without meningitis) improves 6-month all-cause mortality.
Key Objectives
Primary Outcomes
Secondary Outcomes
Achievements
Target enrolment of 600 participants reached in October 2025.
Current Status
Recruitment / Site Participation
100% recruitment (610/600) to date
11 sites in South Africa and Tanzania:
Team Members
Publications and Abstracts
EFFECT News: Edition 1, June 2022
Welcome to the first edition of our newsletter for the EFFECT trial network. It’s fantastic to finally get going after so many months of planning. Our launch meeting in March 2022 was a great opportunity to connect in person with our large multi-country investigator team…
EFFECT News: Edition 2, February 2023
Welcome to the second edition of our newsletter for the EFFECT trial network. It’s fantastic to be open at all South African and Tanzanian sites, and on our way to opening 2 sites in Vietnam! The last four months since we opened to recruitment have been very exciting for us, and for the sites…
EFFECT News: Edition 3, June 2023
We’re now about 8 months into the active recruitment phase of the EFFECT trial. We’re absolutely delighted to have recruited our 100th trial participant in the last week. Congratulations to the site teams across South Africa and Tanzania who have settled into a rhythm and have become most adept at screening, enrolling, navigating the electronic data capture system and reporting AEs.
EFFECT News: Edition 4, December 2023
We have recently celebrated 2 big milestones. In October 2023, we reached one year since our first participant was recruited, and we have just enrolled our 180th participant, marking 30% of our target of 600 participants. All South African sites have now had a second monitoring visit, and Tanzania is due for their second in January 2024…
EFFECT News: Edition 5, September 2024
We kick off our September newsletter with the alert for Fungal Disease Awareness Week, September 16-20, 2024. As you all know, fungal infections are increasing worldwide. How rewarding that we as a team, share the privilege of contributing to advancing knowledge in this crucial area. Please continue to raise awareness in your interactions with other healthcare workers…
2024 Countdown Trials and triumphs: December 2024
2024 has been a year of some triumphant milestones and some trials and tribulations. All of us in the Core team would like to extend our deepest thanks to all of you at the trial sites. We’ve accomplished so much together, so thanks one and all and know that your hard work and commitment is truly appreciated…
EFFECT News: Edition 7, April 2025
Welcome to the 7th edition of our EFFECT newsletter. In this edition, we introduce the Tanzanian team and hear from our MO, David Kabanda, who sadly left the team in February. We also meet Mxolisi, our Port Elizabeth sites Sub-Investigator and get an update from Raphaela Berghammer-Böhmer on her London based MSc experience…
EFFECT News: Edition 8, October 2025
We are delighted to announce that we have successfully reached our recruitment target. Four years, countless hours, and one extraordinary team! This penultimate newsletter marks the successful completion of recruitment, a moment to celebrate the end of a long road, to reflect on the milestones we’ve achieved, and prepare for the end of the EFFECT trial…