Patients who meet the criteria to restart therapy prior to Week 112 proceed to Step 6. Patients receive treatment as in Step 4. 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.
The duration of the induction phase is 52 weeks. Acute HIV infection or recent seroconversion. Written informed consent of parent or guardian if under age 18. Topical and oral antifungal agents, except for oral ketoconazole and itraconazole. Systemic corticosteroids for 21 days or less for acute problems.