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

Completed · Phase 4

Conditions studied: Human Immunodeficiency Virus (HIV) Infection

In brief

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.

Key facts

Study ID

NCT01422330

Run by

Janssen R&D Ireland

People needed

211

Starts

2011-09-01

Expected to finish

2013-11-01

Last updated by the study team

2014-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — North Hollywood, California, United States
• Study site — Fort Laudersale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Akron, Ohio, United States
• Study site — Longview, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Argentina
• Study site — Le Kremlin-Bicêtre, France
• Study site — Paris, France
• Study site — Guatemala City, Guatemala
• Study site — Guadalajara, Mexico
• Study site — México, Mexico
• Study site — Iquitos, Peru
• Study site — Lima, Peru
• Study site — San Juan, Puerto Rico
• Study site — Brasov, Romania
• Study site — Constanța, Romania
• Study site — Craiova, Romania
• Study site — Timișoara, Romania
• Study site — Krasnodar, Russia
• Study site — Moscow, Russia

Full record on ClinicalTrials.gov

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