Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 July 2015 |
Main ID: |
EUCTR2011-001635-23-PL |
Date of registration:
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13/01/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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PROTEA: A clinical trial comparing the efficacy of darunavir/ritonavir 800/100 mg monotherapy versus a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors in patients with
undetectable plasma HIV-1 RNA on current treatment
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Scientific title:
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PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects |
Date of first enrolment:
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14/03/2012 |
Target sample size:
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260 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001635-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: monotherapy vs triple combination therapy
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Austria
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Denmark
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Germany
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Hungary
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Ireland
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Israel
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Italy
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Poland
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31 071 524 21 66 |
Email:
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ClinicaltrialsEU@its.jnj.com |
Affiliation:
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Janssen Biologics |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31 071 524 21 66 |
Email:
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ClinicaltrialsEU@its.jnj.com |
Affiliation:
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Janssen Biologics |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Have documented HIV-1 infection.
2. Be male or female aged >= 18 years old.
3. Criterion deleted per amendment.
4. Criterion modified per amendment.
4.1 Currently be receiving HAART for at least 48 weeks.
Note: HAART is defined as the combination of 2 N(t)RTIs with at least 1 additional ARV (3rd agent) from the non-nucleoside reverse transcriptase (NNRTI), or PI, or
integrase inhibitor class. Subjects should be on their first line HAART, however a previous change in nucleoside backbone, and/or switching within class or between classes for their 3rd agent, for toxicity reasons will be allowed.
5. Criterion modified per amendment.
5.1 Have at least 2 documented plasma HIV-1 RNA <50 copies/mL, and no HIV-1 RNA 50 or over 50 copies/mL in the 48 weeks prior to the screening visit.
6. Be taking the same ARV combination for at least 8 weeks before
screening.
7. Have the preference, together with the physician, to change the
current HAART regimen for reasons of simplification and/or toxicity
(examples of toxicities include but are not limited to: CNS, gastrointestinal disturbances, jaundice, anemia, nausea, neuropathy, paresthesia, hyperlipidemia, glucose intolerance or diabetes, nephrolithiasis, lipodystrophy, hepatotoxicity, rash and skin related events, any other AE or intolerability or laboratory abnormalities caused by current HAART).
8. Criterion modified per amendment.
8.1 Have no CD4+ cell counts below 100 cells/mm3, from the time of first known HIV infection to the start of HAART, and >200 cells/mm3 at screening or a maximum of 4 weeks prior to screening.
9. Be able to comply with the protocol requirements. In particular,
subjects should be willing to be followed up to Week 96 even if they
discontinue randomized treatment.
10. If heterosexually active, a female of childbearing potential and a
non-vasectomized male subject who has a female partner of childbearing potential must agree to use effective contraceptives from screening onwards until 30 days after completion of study treatment.
11. If a woman of childbearing potential, she must have a negative
serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at
screening; and a negative serum or urine pregnancy test before the first dose of study medication to ensure they are not pregnant at the time of starting treatment.
12. Criterion modified per amendment.
12.1 Have voluntarily signed and dated an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria: Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500 copies/mL after initial viral suppression 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.
Note: Subjects with acute viral hepatitis A or C are allowed to be rescreened when their condition is clinically stable and is not expected to require treatment during the study period.
Note: Subjects co-infected with chronic hepatitis C will be allowed to enter the study if their condition is clinically stable and is not expected to require treatment during the study period. See Sections 9.5.5.3 and 9.5.5.4 for further guidelines on enrolment of hepatitis C co-infected subjects.; Is coinfected with hepatitis B
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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HIV-1 infection MedDRA version: 17.1
Level: LLT
Classification code 10020192
Term: HIV-1
System Organ Class: 100000004862
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Trade Name: Prezista Product Name: darunavir-film coated tablet-400mg (F030) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DARUNAVIR CAS Number: 206361-99-1 Current Sponsor code: Darunavir ethanolate (formerly known as TMC114 ethanolate) Other descriptive name: DRV (formerly known as TMC114) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400-
Trade Name: Norvir® Product Name: ritonavir Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RITONAVIR CAS Number: 155213-67-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: 1. the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48 2. change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks 3. the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method. 4. the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96 5. the loss of treatment options as defined by treatment-emergent phenotypic drug resistance 6. the viral genotype of subjects 7. To evaluate and compare safety and tolerability
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Main Objective: The primary objective is to demonstrate non-inferiority in terms of the percentage of subjects who have plasma HIV-1 RNA levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/rtv monotherapy versus triple therapy containing DRV/rtv (FDA Snapshot method).
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Primary end point(s): the percentage of patients who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/ritonavir (rtv) monotherapy versus triple therapy containing DRV/rtv
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Timepoint(s) of evaluation of this end point: 48 weeks
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Secondary Outcome(s)
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Secondary end point(s): the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48
change in neurocognitive function of DRV/rtv monotherapy versus
triple therapy containing DRV/rtv over 48 and 96 weeks
the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method.
the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96
the loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance
the viral genotype of subjects treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks
To evaluate and compare safety and tolerability of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks
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Timepoint(s) of evaluation of this end point: 48 weeks en 96 weeks
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Secondary ID(s)
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2011-001635-23-GB
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TMC114IFD3003
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Source(s) of Monetary Support
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Janssen Medical Affairs
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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