A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
PROTEA
PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects
4 other identifiers
interventional
274
13 countries
34
Brief Summary
The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedStudy Start
First participant enrolled
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2015
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedNovember 27, 2017
October 1, 2017
2.2 years
June 2, 2011
October 30, 2015
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.
Week 48
Secondary Outcomes (6)
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
Week 96
Virologic Response (FDA Snapshot, Switch Included)
Week 48 and 96
Change From Baseline in Global Neurocognitive Performance z-Score
Baseline, Week 48 and 96
Time to Loss of Virologic Response
Baseline up to Week 96 or early withdrawal
Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance
At Weeks 48 and 96
- +1 more secondary outcomes
Study Arms (2)
Darunavir monotherapy
EXPERIMENTALDarunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal. Following the primary efficacy analysis after Week 48, patients who entered the study with a nadir CD4+ count of \<200 cells/μL will also receive 2 N\[t\]RTIs (ie, triple therapy) as soon as possible
Triple therapy containing darunavir
ACTIVE COMPARATORDarunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Interventions
Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use
ritonavir (rtv): type = exact number, unit = mg, number = 100, form = tablet, route = oral use
Eligibility Criteria
You may qualify if:
- HIV-1 infection
- receiving HAART for at least 48 weeks
- Have at least 2 documented plasma HIV-1 RNA \<50 copies/mL, and no HIV-1 RNA \>=50 copies/mL in the 48 weeks prior to the screening
- Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening
- Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity
You may not qualify if:
- Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA \>500 copies/mL while on previous or current antiretroviral therapy
- Has a history of any primary PI mutations
- Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
- Is diagnosed with acute viral hepatitis at screening or before Baseline 1
- Is co-infected with hepatitis B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Graz, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Hvidovre, Denmark
Unknown Facility
Bobigny, France
Unknown Facility
Bondy, France
Unknown Facility
Dijon, France
Unknown Facility
Paris, France
Unknown Facility
Berlin, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Dublin, Ireland
Unknown Facility
Galway, Ireland
Unknown Facility
Beersheba, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Warsaw, Poland
Unknown Facility
Badalona, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Córdoba, Spain
Unknown Facility
Granada, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Stockholm, Sweden
Unknown Facility
Sankt Gallen, Switzerland
Unknown Facility
Zurich, Switzerland
Unknown Facility
Brighton, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Related Publications (1)
Girard PM, Antinori A, Arribas JR, Ripamonti D, Bicer C, Netzle-Sveine B, Hadacek B, Moecklinghoff C. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017 Jan;18(1):5-12. doi: 10.1111/hiv.12386. Epub 2016 Jun 9.
PMID: 27279571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMEA Medical Affairs Program Lead
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2011
First Posted
October 7, 2011
Study Start
March 15, 2012
Primary Completion
June 11, 2014
Study Completion
March 18, 2015
Last Updated
November 27, 2017
Results First Posted
December 3, 2015
Record last verified: 2017-10