- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230580
Protease Inhibitor Monotherapy Versus Ongoing Triple-therapy in the Long Term Management of HIV Infection (PIVOT) (PIVOT)
October 9, 2012 updated by: Medical Research Council
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
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
587
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Vl < 50 for 24 weeks prior to screening CD4 > 100 at screening
Exclusion Criteria:
- Known major protease resistance mutation(s) documented on prior resistance testing if performed (prior resistance testing is not mandatory for trial participation).
- Previous change in ART drug regimen for reasons of unsatisfactory virological response (patients who have changed regimen for prevention or management of toxicity or to improve regimen convenience are permitted to enter the trial).
- Previous allergic reaction to a PI.
- Patient currently using or likely to require use of concomitant medication with known interaction with PIs.
- Patient requiring treatment with radiotherapy, cytotoxic chemotherapy, or is anticipated to need these during the trial period.
- Treatment for acute opportunistic infection within 3 months prior to trial screening.
- Pregnant or trying to become pregnant at the time of trial entry.
- History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments.
- History of HIV encephalopathy with current deficit >1 in any domain of the Neuropsychiatric AIDS Rating Scale (see Appendix 7).
- Past or current history of cardiovascular disease, or 10 year absolute coronary heart disease risk of >30%, or risk of >20% if the patient has diabetes or a family history of premature ischaemic heart disease or stroke.
- History of insulin-dependent diabetes mellitus.
- Patient currently receiving interferon therapy for Hepatitis C virus infection or planning to start treatment for Hepatitis C at the time of trial entry.
- Co-infection with hepatitis B, defined as Hepatitis BsAg positive at screening or at any time since HIV diagnosis, unless the patient has had a documented Hepatitis B DNA measurement of less than 1000 copies/ml taken whilst off Hepatitis B active drugs.
- Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial.
- Fasting plasma glucose >7.0mmol/L at trial screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protease Inhibitor Monotherapy
Ritonavir-boosted protease inhibitor
|
Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
|
Active Comparator: Control
Standard-of-care triple-therapy regimen
|
Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Death from any cause
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Serious AIDS-defining illness
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Serious non-AIDS defining illness
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Confirmed Virological rebound
Time Frame: Up to 5 years
|
Up to 5 years
|
|
CD4+ count change
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Health-related Quality of Life change
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Neurocognitive function change
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Cardiovascular risk change
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Health care costs
Time Frame: Up to 5 years
|
Up to 5 years
|
|
HIV VL in Genital Secretions
Time Frame: Week 96
|
In a sub-set of participants (n=73):-
(Genital Secretions substudy REC # 09/H0305/58) |
Week 96
|
HIV VL in CSF
Time Frame: Week 96
|
In a subset of participants on PI monotherapy (n=40).
(CNS substudy REC # 09/H0305/58). |
Week 96
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nick Paton, MD, Medical Research Council
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
October 27, 2010
First Submitted That Met QC Criteria
October 28, 2010
First Posted (Estimate)
October 29, 2010
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 9, 2012
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Viral Protease Inhibitors
- Protease Inhibitors
- Anti-Retroviral Agents
- HIV Protease Inhibitors
Other Study ID Numbers
- PIVOT
- 2007-006448-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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