17 Oct 2022, Nature Medicine
The eCLEAR study published their results in Nature Medicine in October.
This study combined the use of 3BNC117, which is a broadly neutralising antibody (bNAb), with a potent latency reversing agent, romidepsin, to reduce the HIV reservoir in individuals starting antiretroviral treatment (ART) for the first time.
The study was a phase II multicentre non-blinded randomised controlled trial (RCT) with eligible participants (n=60, 15 per arm) randomised 1:1:1:1 to one of four regimens:
a. ART alone
b. ART + romidepsin
c. ART + 3BNC117
d. ART + romidepsin + 3BNC117
The authors concluded that: “3BNC117 at ART initiation enhanced elimination of plasma viruses and infected cells, enhanced HIV-1-specific CD8+ immunity and was associated with sustained ART-free virologic control among persons with 3BNC117-sensitive virus.
These findings strongly support interventions administered at the time of ART initiation as a strategy to limit long-term HIV-1 persistence.”
The study sponsor was Aarhus University Hospital in Denmark with Professor Ole Schmeltz Søgaard as Chief Investigator. Aarhus Hospital is also in the process of opening as a recruiting site in RIO in 2023.
In the UK, eCLEAR recruited at both St Mary’s Hospital and Guy’s and St Thomas’ Hospital in London. The UK Principal Investigator was Professor Sarah Fidler.