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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.