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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008655-42-DK

Enrollment

150

Registered

2009-02-23

Start date

2009-03-31

Completion date

Unknown

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1

Interventions

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 Curre

Eligibility

Sex/Gender

All

Inclusion 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

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 Bennet 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).

Design outcomes

Primary

Measure	Time frame
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.;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). ;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.	—

Measure

Time frame

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.;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). ;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.

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Countries

Austria, Denmark, France, Germany, Hungary, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026