NCT01230580

Protease Inhibitor Monotherapy Versus Ongoing Triple-therapy in the Long Term Management of HIV Infection (PIVOT)

A Randomised Controlled Trial of a Strategy of Switching to Boosted PI Monotherapy Versus Continuing Combination ART for the Long-term Management of HIV-1 Infected Patients Who Have Achieved Sustained Virological Suppression on HAART

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 587 (actual)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is non-inferior to continuing triple-therapy, in terms of the proportion of patients who maintain all the drug treatment options that were available to them at baseline after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.

Conditions

• HIV Infection
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	Protease Inhibitor	Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
DRUG	Standard-of-care Antiretroviral therapy	Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-10-29
• Last updated: 2012-10-10