PIVOT

Protease Inhibitor monotherapy Versus Ongoing Triple-therapy in the long-term management of HIV infection

Is taking one drug (a protease inhibitor) as good as taking a combination of drugs in the treatment of people with HIV?

What is this study about?

PIVOT aims to compare the use of a single type of anti-HIV medication, protease inhibitors (PI), to the standard triple drug therapy by monitoring the effect on disease progression, drug resistance and death in HIV infected patients.

Currently a combination of three antiretroviral (ART) drugs is used to treat HIV. These drugs seem to be very effective and do not cause many side effects in the short term. However, as they are taken life long they may be associated with side effects after many years.

The results of PIVOT will help inform doctors if it is possible to simplify treatment to just one drug, a PI.

PIVOT will help us learn more about the best ways to treat people with HIV and possibly increase the number of treatment options available for the long term management of HIV disease.

If taking a single anti-HIV drug is shown to be effective, this could result in major savings on NHS drug costs as well as a potential reduction of costs needed to treat the long-term toxicities related to other anti-HIV drugs.

PIVOT also includes a genital secretions substudy and CNS substudy.

Type of study

Randomised trial

Contact details

pivot@ctu.mrc.ac.uk

Who is funding the study?

It is funded by the NIHR Health Technology Assessment (HTA) programme, UK.

When is it taking place?

PIVOT opened to enrolment in November 2008. Participants will be followed to a common closing date five years after the first participant joined, which we anticipate will be November 2013.

Where is it taking place?

PIVOT is taking place at 43 sites in the UK.

Who is included?

587 patients have been included in the trial. All are HIV-infected adults on a stable ART regimen of two Nucleoside Reverse Transcriptase Inhibitor (NRTIs) and one Non- Nucleoside Reverse Transcriptase Inhibitor (NNRTI) or PI. The patients included had CD4+ T-cell counts greater than 100 cells/┬ÁL and viral load (VL) less than 50 copies/ml for no less than 6 months before starting the PIVOT trial. Patients who had virological failure on any previous ART regimen, who had PI resistance mutations, or in whom PIs were contraindicated could not participate.