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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
587
Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor
Loss of future drug options
The first occurrence of intermediate to high level resistance to any one or more of the standard antiretroviral drugs (limited to licensed drugs in contemporary use) to which the patient's virus was considered to be sensitive at trial entry (i.e. excluding drug resistance that was known to be present on previous resistance testing).
Time frame: Up to 5 years
Death from any cause
Time frame: Up to 5 years
Serious AIDS-defining illness
Time frame: Up to 5 years
Serious non-AIDS defining illness
Time frame: Up to 5 years
Adverse events
Time frame: Up to 5 years
Confirmed Virological rebound
Time frame: Up to 5 years
CD4+ count change
Time frame: Up to 5 years
Health-related Quality of Life change
Time frame: Up to 5 years
Neurocognitive function change
Time frame: Up to 5 years
Cardiovascular risk change
Time frame: Up to 5 years
Health care costs
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HIV VL in Genital Secretions
In a sub-set of participants (n=73):- * Compare prevalence of detectable VL and magnitude of viral replication in genital secretions in patients taking PI monotherapy and triple therapy; to test if PI monotherapy is non-inferior to triple therapy. * Compare drug levels in genital secretions and plasma. * Describe the profile of drug resistance (if any) in patients with detectable VL in genital secretions and to compare this with any previous or subsequent resistance profile in plasma. (Genital Secretions substudy REC # 09/H0305/58)
Time frame: Week 96
HIV VL in CSF
In a subset of participants on PI monotherapy (n=40). * Estimate the proportion of patients who have detectable HIV viral load in CSF after 48 weeks on PI monotherapy, and to refute the hypothesis that this proportion is greater than 20%. * Assess whether CSF markers of CNS immune activation, inflammation and neuronal degeneration are elevated after 48 weeks on PI monotherapy. * Assess whether CSF HIV viral load and markers of immune activation, inflammation and neuronal degeneration are elevated in patients with symptomatic CNS disease. (CNS substudy REC # 09/H0305/58).
Time frame: Week 96