RIVER - Research In Viral Eradication of HIV Reservoirs
Research type
Research Study
Full title
RIVER - Research In Viral Eradication of HIV Reservoirs, A two-arm (proof of concept) randomised phase II trial
IRAS ID
162784
Contact name
Sarah Fidler
Contact email
Sponsor organisation
Imperial College London
Eudract number
2014-001425-32
ISRCTN Number
ISRCTN83717528
Clinicaltrials.gov Identifier
Universal Trial Number (UTN), U1111-1163-2579
Duration of Study in the UK
6 years, 11 months, 31 days
Research summary
Current antiretroviral therapy (ART), while allowing HIV-infected persons to lead a healthy life with near-normal life expectancy, cannot cure HIV. If ART is ceased, HIV reappears from the viral reservoir. This HIV reservoir is hidden away inside long-lived dormant (sleeping) cells and is laid down in primary infection i.e. when a person first becomes HIV infected. These dormant cells can be woken up (the ‘kick’) by drugs like vorinostat, an HDAC inhibitor. This ‘kick’ then allows the immune system to ‘kill’ some of the reservoir cells. The aim of this study is to test whether the HIV reservoir can be reduced using a combination approach. In this study we are enrolling patients with primary infection and immediately starting a 4-drug combination ART in order to limit the size of the reservoir. Six months in, and provided the patients are eligible; they are randomised (like the toss of a coin) into one of 2 arms. In the first Arm, patients continue 4-drug ART. In the second Arm, patients continue 4-drug ART but in addition receive two different anti-HIV vaccines 8 weeks apart followed by 10 doses of vorinostat over 28 days. The vaccines should boost the immune system’s ability to kill reservoir cells activated by vorinostat. The strategy is known as ‘kick and kill’. We plan to enrol 52 people with 26 in each Arm. There are 15 study visits over 42 weeks with the same safety checks and blood draws. We believe the ‘kick and kill’ approach will significantly reduce the amount of HIV reservoir as measured by a blood draw at weeks 40 and 42 compared to using 4-drug ART alone. This is a ‘proof-of-principle’ study, it is really testing whether this strategy does actually reduce the size of the HIV reservoir and is safe.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1372
Date of REC Opinion
23 Dec 2014
REC opinion
Further Information Favourable Opinion