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The PIVOT trial reaches its recruitment target

24 September 2010

The PIVOT (Protease Inhibitor monotherapy Versus Ongoing Triple Therapy) trial aims to determine if treating HIV infection with one class of drugs is just as good as the standard treatment of 3 drugs, in the long term, for participants who have had undetectable viral load for at least 6 months.

Recruitment to the trial has been extremely successful. The original recruitment target of 400 participants was achieved in March 2010, 2 months ahead of the planned recruitment target date.

Recruitment was extended in order to ensure that the aim of demonstrating that taking one drug (a protease inhibitor) is as good as taking a combination of drugs is achieved. The new recruitment target was reached on 28th July 2010. 587 patients have been recruited from 43 sites in the UK making PIVOT the largest MRC-sponsored, UK-based, HIV, randomised clinical trial since 1994 i.e. since the advent of HAART (Highly Active Anti-Retroviral Therapy). 10 sites recruited 20 or more participants and 19 sites recruited 10 or more patients. Patients will be followed up until a common closing date for the trial of November 2013.

We will be recruiting patients from the main PIVOT trial into 2 substudies to look at the effect of PI monotherapy on HIV in the Central Nervous System and in the Genital tract.

We would like to thank the participants and the staff at the sites for making recruitment to PIVOT so successful.

The PIVOT team (mrcctu.pivot@ucl.ac.uk)