TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.

Key facts

Study ID

NCT00071097

Run by

Tibotec Pharmaceuticals, Ireland

People needed

330

Starts

2003-10-01

Expected to finish

2007-11-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 18 years or older
• Documented HIV-1 infection
• Stable PI regimen for at least 8 weeks prior to screening
• Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
• Prior use of more than 1 NRTI for at least 3 months
• Prior use of one or more NNRTIs as part of a failing regimen
• At least 1 primary PI mutation as defined by the IAS guidelines
• Treatment with at least 1 PI for a total of at least 3 months
• Patient has given informed consent

You may not qualify if…

• Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
• Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
• NNRTI as part of therapy at screening
• Patients on a treatment interruption at screening
• Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening
• Hepatitis A, B, or C.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, 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 — Oakland, California, United States
• Study site — San Diego, 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 — Altamonte Springs, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, 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 — Baltimore, Maryland, 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

Full record on ClinicalTrials.gov

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