An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

Completed · Phase 3

Conditions studied: HIV-1

In brief

The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

Key facts

Study ID

NCT00359021

Run by

Tibotec Pharmaceuticals, Ireland

People needed

503

Starts

2006-06-01

Expected to finish

2012-01-01

Last updated by the study team

2014-05-16

Who can join

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

You may qualify if…

• Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
• Patient was virologically failing in a DUET trial.

You may not qualify if…

• Use of disallowed concomitant therapy
• Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
• Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Laudersale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Camden, New Jersey, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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