Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. 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.
Clinical stability, in the opinion of the investigator, for at least 14 days prior to study entry. Willingness to discontinue all antiretroviral therapy unrelated to the study prior to study entry. Treatment for chronic opportunistic infections as long as medications stable for at least 14 days prior to study entry. Treatment for a chronic, stable opportunistic infection or prophylaxis for opportunistic infections consistent with standard treatment. Active pulmonary disease, as evidenced by chest x-ray, within 21 days of study entry.