Patients stop study medications and interrupt potent antiretroviral therapy for 6 to 16 weeks. Patients resume their original potent antiretroviral therapy regimen for 6 to 10 weeks and are monitored for a minimum of 6 weeks. 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.
25 patients per arm. Documentation of a previous test within 45 days of study entry is acceptable for the screening value. Within 45 days prior to study entry. Within 45 days prior to study entry. Within 45 days prior to study entry.