Randomization is stratified for baseline phenotypic sensitivity. Randomization is stratified for baseline phenotypic sensitivity. 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.
Phenotypically documented sensitivity to BMS-232632, RTV, and SQV defined as less than 10 times the EC50 of the control strain. Availability for follow-up for a period of at least 48 weeks. History of acute or chronic pancreatitis. Acute hepatitis within 30 days of study entry. History of bilateral peripheral neuropathy.