Main
|
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:
|
EUCTR |
Last refreshed on:
|
8 October 2021 |
Main ID: |
EUCTR2008-008655-42-FR |
Date of registration:
|
17/04/2009 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Phase IIb, multi-centre, randomised, double-blind, active-controlled, trial comparing the neuropsychiatric adverse event profile of etravirine 400 mg q.d. versus efavirenz 600 mg q.d. in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral therapy-naïve HIV-1 infected subjects. - SENSE
|
Scientific title:
|
A Phase IIb, multi-centre, randomised, double-blind, active-controlled, trial comparing the neuropsychiatric adverse event profile of etravirine 400 mg q.d. versus efavirenz 600 mg q.d. in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral therapy-naïve HIV-1 infected subjects. - SENSE |
Date of first enrolment:
|
03/06/2009 |
Target sample size:
|
150 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008655-42 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: active-controlled If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Austria
|
Denmark
|
France
|
Germany
|
Hungary
|
Italy
|
Spain
|
United Kingdom
|
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: • Documented HIV-1 infection. • In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the subject’s medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection. • Subject has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection. • HIV-1 plasma viral load at screening = 5,000 HIV-1 RNA. • Predicted phenotypic sensitivity at screening to the currently approved NNRTIs (EFV, ETR and NVP) and to the N(t)RTIs in their background regimen. 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: • Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission. • The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance as described by Shafer et al. • Known infection with HIV-2 or with HIV-1 group O. • Subject has any currently active AIDS defining illness (Category C conditions). • Grade 3 or 4 laboratory abnormalities (with exceptions, as per section 4).
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
HIV-1 infection MedDRA version: 9.1
Level: LLT
Classification code 10020192
Term: HIV-1
|
Intervention(s)
|
Trade Name: Intelence 100mg tablets Product Name: etravirine (ETR, TMC125) Product Code: TMC125 (R165335) F060 Pharmaceutical Form: Tablet INN or Proposed INN: etravirine CAS Number: 269055-15-4 Current Sponsor code: ETR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Sustiva Product Name: Sustiva 600 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: efavirenz CAS Number: 154598-52-4 Current Sponsor code: EFV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
|
Primary Outcome(s)
|
Primary end point(s): The primary endpoint is the proportion of subjects with at least one treatment-emergent Grade 1-4 CNS or psychiatric adverse event, observed between Baseline through Week 12, as judged by the investigator to be at least possibly drug related to the study drug, in the ETR group versus the control group (EFV).
|
Main Objective: To compare the proportion of subjects with at least one treatment-emergent Grade 1-4 CNS or psychiatric adverse event, observed between Baseline through Week 12 and judged by the investigator to be at least possibly related to the study drug, in the ETR group versus the control group (EFV), respectively.
|
Secondary Objective: To evaluate and compare ETR vs EFV over 48 wks regarding • Antiviral activity as determined by plasma viral load • Mean worst score during the treatment period in IMP tolerability according to the CNS and total Tolerability score, as calculated from subject report on the HIV Patient Symptoms Profile • Percentage of subjects with at least one treatment-emergent Grade 1-4 CNS or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug • Incidence of treatment-limiting psychiatric and/or CNS adverse events • Safety and tolerability • Immunologic changes (as measured by CD4+ T-cell count change from Baseline, absolute and percentage) • Adverse events of special interest, including but not limited to rash, hyperlipidaemia and lipoatrophy • To assess the evolution of the viral genotype and phenotype • To evaluate the population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationships for efficacy and safety of ETR.
|
Secondary ID(s)
|
2008-008655-42-DK
|
TMC125VIR2038
|
Source(s) of Monetary Support
|
Ethics review
|
Status: Approved
Approval date: 04/05/2009
Contact:
|
|