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Clinical Trials/EUCTR2010-023532-16-RO
EUCTR2010-023532-16-RO
Active, not recruiting
Phase 1

An open-label study to evaluate the safety, tolerability and pharmacokinetics of etravirine (ETR) in combination with other antiretrovirals (ARVs) in antiretroviral treatment-experienced HIV-1 infected subjects. -

Janssen R&D Ireland0 sites211 target enrollmentOctober 9, 2012
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Janssen R&D Ireland
Enrollment
211
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 9, 2012
End Date
November 11, 2013
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Janssen R&D Ireland

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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