A patient's HIV must be sensitive to at least 3 drugs. Patients have regular clinic visits for physical exams and blood tests, including CD4 and CD8 cell counts, plasma HIV-1 RNA assays, and tests for pharmacokinetic variability. 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 plasma HIV-1 RNA sample obtained at study screening can serve as the confirmatory test and must be performed within 16 weeks of the initial rebound. An evaluable phenotypic resistance assay result from ViroLogic, Inc. at study entry indicating the virus is sensitive to 3 or more drugs. At least 2 other drugs must be part of the patient's current, initial ART regimen. Signed, informed consent by a parent or legal guardian for patients under age 18. Acupuncture and visualization techniques.