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

Phase 1

• Conditions: HIV-1 infection; MedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1

• Registration Number: EUCTR2008-008655-42-FR
• Lead Sponsor: Janssen Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-17
• Study Completion: 2011-01-12
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified