Pharmacokinetic samples are collected on Day 21 and analyzed. Patients receive study drug for at least 48 weeks on an outpatient basis. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
At least 48 weeks. Vital signs, physical exam, and laboratory results that do not exhibit evidence of acute illness. Within 45 days prior to initial dosing. Previous therapy with at least 2 protease inhibitors and at least 1 nonnucleoside reverse transcriptase inhibitor. Intolerance to ritonavir dose of 300 mg twice daily.