TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV

In brief

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.

Key facts

Study ID

NCT00254046

Run by

Tibotec Pharmaceuticals, Ireland

People needed

616

Starts

2005-11-01

Expected to finish

2008-07-01

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…

• Patient has 3 or more primary protease inhibitor mutations
• documented genotypic evidence of resistance to currently available NNRTIs by having at least 1 NNRTI (non-nucleoside reverse transcriptase inhibitors) resistance-associated mutation
• on a stable antiretroviral therapy for at least 8 weeks
• plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.

You may not qualify if…

• Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
• Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
• Use of disallowed concurrent therapy
• Any active clinically significant disease

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — New Haven, Connecticut, 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 — North Miami Beach, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Wichita, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Little Rock, Arkansas, 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.