TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

Completed · Phase 3

Conditions studied: HIV Infection

In brief

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Key facts

Study ID

NCT00110877

Run by

Tibotec Pharmaceuticals, Ireland

People needed

604

Starts

2005-04-01

Expected to finish

2011-10-01

Last updated by the study team

2015-07-03

Who can join

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

You may qualify if…

• Patient has documented HIV-1 infection
• Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
• Plasma HIV-1 RNA >1000 copies/mL
• General medical condition does not interfere with the assessments and the completion of the trial

You may not qualify if…

• Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
• tenofovir, emtricitabine, atazanavir, fosamprenavir
• Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
• Life expectancy of less than 6 months
• Pregnant or breast-feeding
• Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
• Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
• Participation in other investigational trials without prior approval of the sponsor

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 — San Francisco, California, United States
• Study site — West Hollywood, 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 — Miami, Florida, United States
• Study site — Orlando, 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 — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Berkley, Michigan, United States
• Study site — Camden, New Jersey, United States
• Study site — East Orange, New Jersey, United States
• Study site — Newark, New Jersey, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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