The VIOLIN Study: to Evaluate etravirine Tolerability, Pharmacokinetics With Other Antiretrovirals In Treatment Experienced Patients

Phase 1

• Conditions: HIV-1 infection; MedDRA version: 19.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-023532-16-RO
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-09
• Study Completion: 2013-11-11
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Have not changed your drugs to treat HIV for 8 weeks and currently experiencing virologic failure, (viral load value = 500 HIV 1 RNA copies /mL); or switching due to simplification of their regimen or due to adverse event or tolerability reasons, (viral load value <50 HIV 1 RNA copies /mL). You must have demonstrated sensitivity to ETR and to at least 1 ARV in the background regimen, based on the resistance test for subjects with a screening viral load = 500 HIV-1 RNA copies/mL or based on historical ARV resistance testing or ARV treatment history for
those group of subjects entering the study with a plasma viral load < 50 HIV-1 RNA copies/mL. You must agree not to have unprotected sex while on the study. You must not have a currently active AIDS defining illness. You must not take any non-ARV investigational agents within 90 days prior to screening. You must not use of any drugs or other therapies that your doctors tell you are disallowed. Your doctor must check that your liver is functioning correctly. Any disease that in your study doctor's opinion, would compromise the subject's safety.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Any currently active illness or toxicity due to your HIV infection

Study & Design

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