Protease Inhibitor Monotherapy Versus Ongoing Triple-therapy in the Long Term Management of HIV Infection (PIVOT) (PIVOT)
|ClinicalTrials.gov Identifier: NCT01230580|
Recruitment Status : Unknown
Verified October 2010 by Medical Research Council.
Recruitment status was: Active, not recruiting
First Posted : October 29, 2010
Last Update Posted : October 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Acquired Immunodeficiency Syndrome||Drug: Protease Inhibitor Drug: Standard-of-care Antiretroviral therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||587 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
Experimental: Protease Inhibitor Monotherapy
Ritonavir-boosted protease inhibitor
Drug: Protease Inhibitor
Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
Active Comparator: Control
Standard-of-care triple-therapy regimen
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
- Loss of future drug options [ Time Frame: Up to 5 years ]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).
- 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 ]
- HIV VL in Genital Secretions [ Time Frame: Week 96 ]
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)
- HIV VL in CSF [ Time Frame: Week 96 ]
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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230580
|Principal Investigator:||Nick Paton, MD||Medical Research Council|