TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

Completed · Phase 3

Conditions studied: HIV

In brief

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

Key facts

Study ID

NCT00258557

Run by

Tibotec Pharmaceuticals, Ireland

People needed

692

Starts

2005-09-01

Expected to finish

2012-05-01

Last updated by the study team

2013-06-26

Who can join

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

You may qualify if…

• Patients with documented HIV-1 infection
• Screening plasma HIV-1 RNA >= 5000 copies/mL
• Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
• Patients who can comply with the protocol requirements
• General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

You may not qualify if…

• Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
• Life expectancy of less than 6 months
• Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
• Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
• -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) < 70 mL/min

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, 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 — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, 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 — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Brooklyn, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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