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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Anti-Retroviral Agents; Etravirine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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