All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts. At Week 24, all patients are crossed over to SAT for an additional 48 weeks of follow-up. 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.
A history of Grade 2 or higher bilateral peripheral neuropathy within 60 days prior to study entry. A history of pancreatitis. Current alcohol abuse, at the discretion of the local investigator. Investigational drugs and vaccines. Rifabutin or rifampin.