An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Completed · Phase 2

Conditions studied: HIV Infection

In brief

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

Key facts

Study ID

NCT00081588

Run by

Tibotec Pharmaceuticals, Ireland

People needed

555

Starts

2003-11-01

Expected to finish

2008-12-01

Last updated by the study team

2014-06-20

Who can join

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

You may qualify if…

• Previous participation in the TMC114-C202 or TMC114-C213 trials
• Significant virologic failure during participation in the above trials
• Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
• Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
• Patient has given informed consent

You may not qualify if…

• Use of disallowed concomitant therapy
• Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
• Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
• Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
• Patient withdrawing consent from TMC114-C202 or TMC114-C213

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — San Francisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Camden, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Birmingham, Alabama, 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.