A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

Completed · Phase 3

Conditions studied: HIV-1 Infection

In brief

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

Key facts

Study ID

NCT01266902

Run by

Janssen R&D Ireland

People needed

482

Starts

2011-02-01

Expected to finish

2020-02-01

Last updated by the study team

2021-03-04

Who can join

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

You may qualify if…

• Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
• Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
• Patient can comply with the current protocol requirements.
• The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.

You may not qualify if…

• Use of disallowed concomitant therapy.
• Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
• Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).

Where it is running

• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.