Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Human Immunodeficiency Virus (HIV) Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity...
Detailed Description
This is an open-label (all people involved know the identity of the intervention), single arm, multicenter Phase IV study to evaluate the safety, tolerability, and pharmacokinetics of etravirine (ETR)...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection
- Treatment with current stable HAART for at least 8 weeks prior to screening
- Currently experiencing virologic failure (screening 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, (screening viral load value \<50 HIV-1 RNA copies /mL)
- Demonstrated sensitivity to etravirine and to at least 1 antiretroviral (ARV) agent in the background regimen, based on the resistance test at screening or resistance history or have previously received treatment with etravirine
- Patients agree not to have unprotected sex while on the study
- No currently active AIDS-defining illness
- Did not take any non-ARV investigational agents within 90 days prior to screening
- No use of disallowed treatments
- Adequate liver function
Exclusion
- Any currently active illness or toxicity due to HIV infection
- Any active clinically significant disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01422330
Start Date
September 1 2011
End Date
November 1 2013
Last Update
October 13 2014
Active Locations (42)
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1
Phoenix, Arizona, United States
2
Beverly Hills, California, United States
3
North Hollywood, California, United States
4
Fort Laudersale, Florida, United States