TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the antiviral activity, safety and tolerability of 14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is failing on a current treatment regimen that includes a protease inhibitor (PI) (a medication used to reduce the amount of HIV virus in the blood).To be considered for the study, patients must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and pharmacodynamics of TMC114 will also be assessed.

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

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Antiviral Agents; Darunavir; Protease Inhibitors

Criteria

Inclusion Criteria:

• Patient has a documented HIV-1 infection with a viral load at screening visit above 2,000 HIV copies/ml

• Currently treated with a failing antiretroviral regimen consisting of NRTIs together with one or more PI(s)

• Has a resistance against at least 2 of the currently used PIs

• Patient agrees not to change the current therapy until end of run-in and agrees not to change NRTIs until the end of treatment period

• No current AIDS defining illnesses

Exclusion Criteria:

• NNRTI (non-nucleoside reverse transcriptase inhibitor) containing regimen, two weeks prior to screening

• Suspicion of alcohol abuse or drug abuse, leading to non-compliance

• History of significant drug allergy induced by PIs

• CD4 count < 50

• Life expectancy of less than 6 months

• Pregnant or breast feeding females

• Females of childbearing potential without use of a highly effective birth control method or not willing to continue practicing this birth control method for at least 14 days after the end of the treatment

• Received an investigational drug within 30 days prior to the trial drug administration

• Patients with clinically significant laboratory abnormalities.