Analyses for patient safety and drug efficacy are done at Weeks 8 and 24 using results from clinical laboratory tests and physical exams. Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 24 weeks of treatment. 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.
A minimum of 30 patients. Oral or subcutaneous contraceptives should not be used as the only method of birth control. If study medication is discontinued, patients should continue to use contraception for the subsequent 3 months. Vaccines may be administered at the time of a study visit only after blood samples have been drawn. Virologic failure of any regimen containing an HIV protease inhibitor.