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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. |
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Register:
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EUCTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
EUCTR2010-020860-39-GB |
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Date of registration:
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17/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION
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Scientific title:
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A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION |
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Date of first enrolment:
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20/12/2010 |
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Target sample size:
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160 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020860-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Portugal
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Completion of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols.
3. HIV-1 RNA level <50 copies/mL at Week 84 of the parent protocol(if the HIV-1 RNA
level is =50 copies/mL at Week 84, a second HIV-1 RNA level must be performed and
confirmed to be <50 copies/mL prior to the Week 96 visit of the parent protocol).
4. Considered by the investigator to be an appropriate candidate for continued treatment with lersivirine (or comparator, where required by local regulation) plus the background therapy defined in the parent protocol.
5. Negative urine pregnancy test for Women of Child Bearing Potential (WOCBP) at the Day 1 visit, prior to receiving study medication. See Section 4.3.
6. Use of effective double barrier contraception for WOCBP for the duration of the study and for 28 days after leaving the study. For WOCBP treated with efavirenz, this period should be for the duration of the study and for 12 weeks after leaving the study. Use of effective barrier contraception for males for the duration of the study. See Section 4.3.
7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
1. Presence of any Grade 4 Division of AIDS (DAIDS) toxicity (except for lipids and
asymptomatic glucose elevations and those discussed and agreed by the investigator and the Sponsor’s Medical Monitor prior to enrollment).
2. Use of prohibited concomitant medications, as defined in Section 5.5, Concomitant
Medications.
3. Concurrent treatment with another investigational product or in another clinical trial, except the lersivirine parent protocols.
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of HIV-1 infection in combination with other agents in antiretroviral treatment naive and antiretroviral treatment-experienced subjects.
MedDRA version: 12.1
Level: LLT
Classification code 10068341
Term: HIV-1 infection
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Intervention(s)
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Product Name: Lersivirine
Product Code: UK-453,061
Pharmaceutical Form: Tablet
INN or Proposed INN: Lersivirine
CAS Number: 473921-12-9
Current Sponsor code: UK-453,061
Other descriptive name: 5-[[3,5-diethyl-1-(2-hydroxyethyl) -1H-pyrazol-4-yl]oxy]-1,3- benzene dicarbonitrile
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
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Primary Outcome(s)
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Main Objective: To assess the long-term safety and efficacy of lersivirine in subjects who have
completed treatment with lersivirine in the parent protocols.
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Primary end point(s): > Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests.
> The percentage of subjects with HIV-1 RNA level <50 copies/mL at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol).
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Secondary Objective: None
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Source(s) of Monetary Support
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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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