Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. 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.
Consent of parent or guardian if under 18 years of age. Within 30 days of study randomization. Within 30 days of study randomization. Alternative therapies such as acupuncture and visualization. Initiation of potent antiretroviral therapy occurring outside a clinical trial.