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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. |
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Register:
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EUCTR |
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Last refreshed on:
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27 July 2020 |
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Main ID: |
EUCTR2007-004379-20-GB |
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Date of registration:
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17/11/2008 |
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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 PHASE 2B MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF UK-453,061, IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE VERSUS EFAVIRENZ IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE FOR THE TREATMENT OF ANTIRETROVIRAL-NAIVE HIV-1 INFECTED SUBJECTS
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Scientific title:
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A PHASE 2B MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF UK-453,061, IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE VERSUS EFAVIRENZ IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE FOR THE TREATMENT OF ANTIRETROVIRAL-NAIVE HIV-1 INFECTED SUBJECTS |
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Date of first enrolment:
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11/12/2008 |
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Target sample size:
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189 |
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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:2007-004379-20 |
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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: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Italy
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Poland
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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 trial:
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. Male or female at least 18 years of age available for a follow-up period of at least
96 weeks.
3. HIV-1 RNA viral load of =1,000 copies/mL measured by the Roche Roche Amplicor® HIV-1 Monitor test at the screening visit.
4. Negative urine pregnancy test at the Day 1 visit, prior to receiving the first dose of study medication, for Women of Child Bearing Potential (WOCBP).
• NOTE: WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal (ie, no menstrual periods for at least 2 years). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods: eg,condom or diaphragm with spermicide) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing potential.
5. Effective barrier contraception for WOCBP and males. In addition, WOCBP must use another acceptable method of contraception for the duration of the study and for 12 weeks after leaving the study. Acceptable contraception includes, but is not limited to, oral, implanted or injectable hormone therapy and intrauterine devices.
6. Subjects who are 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:
Key Exclusion Criteria have been selected (please refer to Protocol for the completed list):
Subjects presenting with any of the following will not be included in the trial:
1. Suspected or documented active, untreated HIV-1 related OI or other condition requiring acute therapy at the time of randomization with the following exceptions:
•Subjects on a stable (>30 days) secondary OI prophylaxis regimen or chronic treatment.
•Subjects on a primary OI prophylaxis regimen of any duration. However, subjects being treated with trimethoprim-sulfamethoxazole must be on stable therapy (>60 days) to be eligible.
2. Subjects on therapy for Hepatitis B.
3. Subjects with acute Hepatitis B and/or C within 30 days of randomization.
4. Subjects with Hepatitis C on therapy with interferon and/or ribavirin for <60 days.
However, subjects diagnosed with Hepatitis C may be treated for Hepatitis C during the study if deemed appropriate by the subject’s physician.
5. Absolute CD4+ cell count <200 cells/mm3.
6. Treatment for an active OI, or unexplained temperature >38.5 °C, for 7 consecutive days within 30 days prior to randomization.
7. Prior treatment with efavirenz, emtricitabine, or tenofovir DF, or with any other antiretroviral therapy for more than 14 cumulative days at any time.
12. Malignancy requiring systemic therapy that must be continued during the trial.
14. Renal insufficiency defined as a serum creatinine greater than 3 times the upper limit of normal or creatinine clearance of less than 50mL/min. Creatinine clearance will be calculated by the Investigator using the Cockcroft and Gault equation
15. Total bilirubin greater than 1.5 times the upper limit of normal.
16. AST and/or ALT greater than 3 times the upper limit of normal.
17. Male subjects with a baseline QT of >450 msec and female subjects with a baseline QT of >470 msec.
18. Presence of risk factors for prolongation of QT interval including heart failure, chronic hypokalemia, family history of long QT syndrome, concomitant use of medications that are known to prolong QT interval.
24. Presence of gross hematuria or grade 4 proteinuria at the time of screening.
30. Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including immunomodulators for the treatment of HIV-1 infection. Interferon for the ongoing treatment of hepatitis C infection is permitted.
Note: It is incumbent upon the investigator to be thoroughly familiar with the prescribing information for the study drugs.
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 in particular against drug-resistant virus, especially the clinically significant mutants (K103N, Y181C, and L100I)
MedDRA version: 9.1
Level: PT
Classification code 10020161
Term: HIV infection
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Intervention(s)
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Product Name: Lersivirine
Product Code: UK-453,061
Pharmaceutical Form: Tablet
CAS Number: 473921-12-9
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-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Sustiva
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective is to assess efficacy of UK-453,061 when used in combination with tenofovir DF/emtricitabine, as measured by the percentage of subjects with HIV-1 RNA <50 copies/mL at 48 weeks.
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Secondary Objective: • To assess efficacy as measured by percentage of subjects with HIV-1 RNA <50 and <400 copies/mL.
•To assess Change from baseline in log10 transformed HIV-1 RNA levels.
•To assess safety and tolerability of UK-453,061.
• To assess the pharmacokinetic (PK) and pharmacokinetic/ pharmacodynamic (PK/PD) relationship of UK-453,061.
• To assess pharmacokinetic parameters of UK-453,061 AUC24,Cmax and C24h (PK substudy).
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Primary end point(s): Percentage of subjects with HIV-1 RNA <50 copies/mL at 48 weeks.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 28/11/2008
Contact:
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